Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01151410 | An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age | PHASE3 | COMPLETED | 208 | — | — | Aug 1, 2010 | Aug 1, 2015 | Mar 7, 2016 | 36 | United States, Guatemala +5 |
| NCT01150357 | Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age | PHASE3 | COMPLETED | 267 | — | — | Jun 1, 2010 | Aug 1, 2014 | Oct 15, 2015 | 48 | United States, Belgium +7 |
| NCT00867490 | Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension | PHASE3 | COMPLETED | 186 | — | — | Mar 1, 2009 | Aug 1, 2009 | May 6, 2011 | 1 | Germany |
| NCT00797862 | Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension | PHASE3 | COMPLETED | 1,254 | — | — | Nov 1, 2008 | Nov 1, 2010 | Oct 17, 2011 | 10 | Canada, Costa Rica +8 |
| NCT00777946 | Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone | PHASE3 | COMPLETED | 818 | — | — | Oct 1, 2008 | May 1, 2009 | Jul 12, 2011 | 9 | Estonia, France +7 |
| NCT00765674 | Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension | PHASE3 | COMPLETED | 1,191 | — | — | Sep 1, 2008 | Aug 1, 2009 | May 9, 2011 | 12 | United States, Australia +10 |
| NCT00739973 | Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension | PHASE3 | COMPLETED | 2,694 | — | — | Sep 1, 2008 | May 1, 2009 | Jun 6, 2011 | 18 | United States, Argentina +16 |
| NCT00705575 | Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension | PHASE3 | COMPLETED | 688 | — | — | Jun 1, 2008 | Apr 1, 2009 | May 30, 2011 | 8 | United States, Argentina +6 |
| NCT00706134 | Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study | PHASE3 | COMPLETED | 756 | — | — | May 1, 2008 | Apr 1, 2009 | Jun 28, 2011 | 8 | Argentina, Czechia +6 |
| NCT00529451 | Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg | PHASE3 | COMPLETED | 1,613 | — | — | Sep 1, 2007 | Jul 1, 2008 | Mar 25, 2011 | 3 | China, India +1 |
| NCT00402103 | An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure | PHASE3 | COMPLETED | 556 | — | — | Nov 1, 2006 | Apr 1, 2008 | Mar 10, 2011 | 8 | United States, Belgium +6 |
| NCT00387517 | Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension | PHASE3 | COMPLETED | 726 | — | — | Oct 1, 2006 | Aug 1, 2007 | Feb 7, 2017 | 2 | United States, Germany |
| NCT00386607 | A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. | PHASE3 | COMPLETED | 601 | — | — | Oct 1, 2006 | Jul 1, 2008 | Feb 10, 2014 | 4 | United States, Canada +2 |
| NCT00386139 | A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients | PHASE3 | COMPLETED | 881 | — | — | Sep 1, 2006 | Jul 1, 2007 | Feb 7, 2017 | 2 | United States, Germany |
| NCT00368277 | A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly | PHASE3 | COMPLETED | 901 | — | — | Sep 1, 2006 | Feb 1, 2008 | Mar 25, 2011 | 1 | United States |
| NCT00344110 | Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension | PHASE3 | COMPLETED | 768 | — | — | Jun 1, 2006 | Apr 1, 2007 | Nov 18, 2016 | 1 | Japan |
| NCT00299832 | SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction | PHASE3 | COMPLETED | 40 | — | — | Apr 1, 2006 | May 1, 2007 | Nov 18, 2016 | 1 | Japan |
| NCT00299806 | SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension | PHASE3 | COMPLETED | 39 | — | — | Apr 1, 2006 | Nov 1, 2006 | Nov 18, 2016 | 1 | Japan |
| NCT00262236 | Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension | PHASE3 | COMPLETED | 693 | — | — | Nov 1, 2005 | Aug 1, 2006 | Nov 18, 2016 | 2 | Germany, Switzerland |
| NCT00260923 | A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure | PHASE3 | COMPLETED | 641 | — | — | Nov 1, 2005 | Nov 1, 2006 | Nov 8, 2011 | 2 | United States, Germany |
| NCT00219193 | A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients | PHASE3 | COMPLETED | 641 | — | — | Oct 1, 2005 | Jan 1, 2007 | Feb 7, 2017 | 2 | United States, Germany |
| NCT00518765 | Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet | PHASE3 | COMPLETED | 32 | — | — | Oct 1, 2005 | - | Oct 6, 2010 | 1 | United States |
| NCT00219102 | A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients | PHASE3 | COMPLETED | 336 | — | — | Jun 1, 2005 | May 1, 2007 | Feb 11, 2020 | 7 | United States, Belgium +5 |
| NCT00171405 | A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg | PHASE3 | COMPLETED | 250 | — | — | Jun 1, 2005 | Feb 1, 2006 | Nov 18, 2016 | 10 | United States, Belgium +8 |
| NCT00219180 | Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure | PHASE3 | COMPLETED | 1,797 | — | — | Jun 1, 2005 | Sep 1, 2006 | May 17, 2017 | 2 | United States, Germany |
| NCT00219167 | A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure | PHASE3 | COMPLETED | 355 | — | — | Apr 1, 2005 | Feb 1, 2006 | Nov 18, 2016 | 1 | Switzerland |
| NCT00219154 | A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine | PHASE3 | COMPLETED | 1,125 | — | — | Mar 1, 2005 | Jan 1, 2006 | Nov 8, 2011 | 2 | Germany, Switzerland |
| NCT00294710 | A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine | PHASE3 | COMPLETED | 976 | — | — | Mar 1, 2005 | Jul 1, 2006 | Nov 8, 2011 | 2 | United States, Germany |
| NCT00219076 | A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients | PHASE3 | COMPLETED | 504 | — | — | Feb 1, 2005 | - | May 18, 2017 | 2 | United States, Germany |
| NCT00219063 | A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal. | PHASE3 | COMPLETED | 844 | — | — | Feb 1, 2005 | Mar 1, 2006 | May 17, 2017 | 1 | United States |
| NCT00219050 | A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension | PHASE3 | COMPLETED | 180 | — | — | Feb 1, 2005 | Nov 1, 2005 | Feb 25, 2011 | 4 | Germany, Hungary +2 |
| NCT00219115 | A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg | PHASE3 | COMPLETED | 493 | — | — | Jan 1, 2005 | Mar 1, 2006 | Feb 7, 2017 | 2 | United States, Germany |
| NCT00219128 | A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure. | PHASE3 | COMPLETED | 671 | — | — | Nov 1, 2004 | Jun 1, 2005 | Nov 8, 2011 | 1 | United States |
| NCT00219024 | Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension. | PHASE3 | COMPLETED | 2,775 | — | — | Aug 1, 2004 | Jun 1, 2005 | May 17, 2017 | 2 | United States, Germany |
| NCT00219037 | Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension | PHASE3 | COMPLETED | 1,955 | — | — | Jun 1, 2004 | Oct 1, 2005 | Nov 8, 2011 | 1 | Germany |
| NCT00939588 | Compare the Effect of Aliskiren Plus Valsartan Versus Angiotensin-Converting Enzyme Inhibitor (ACEi) Plus Angiotensin Receptor Blocker (ARB) [Ramipril Plus Telmisartan] on the Renin-Angiotensin-Aldosterone System (RAAS) in Hypertensive Patients | PHASE2 | COMPLETED | 88 | — | — | Jul 1, 2009 | - | Nov 18, 2016 | 1 | Russia |
| NCT00819767 | Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise | PHASE2 | COMPLETED | 68 | — | — | Feb 1, 2009 | Oct 1, 2009 | Jun 28, 2011 | 8 | Czechia, Hungary +2 |
| NCT00311012 | SPP100 Dose Finding Study in Japan | PHASE2 | COMPLETED | 445 | — | — | Aug 1, 2004 | Mar 1, 2005 | Nov 8, 2011 | 1 | Japan |
| NCT00933920 | Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension | PHASE1 | COMPLETED | 124 | — | — | Jun 1, 2009 | - | Dec 21, 2020 | 5 | India |
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.
| Arm | Type | Description |
|---|---|---|
| Aliskiren | EXPERIMENTAL | Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
| Enalapril | ACTIVE_COMPARATOR | Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
| Low Dose Aliskiren | EXPERIMENTAL | Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. |
| Mid dose | EXPERIMENTAL | Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. |
| High dose | EXPERIMENTAL | Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren. |
| Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine | EXPERIMENTAL | - |
| Aliskiren + Amlodipine | EXPERIMENTAL | Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Aliskiren Start - Amlodipine Add-On | EXPERIMENTAL | Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Amlodipine Start- Aliskiren Add-On | EXPERIMENTAL | Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks. |
| Aliskiren 300 mg/Amlodipine 5 mg | EXPERIMENTAL | Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. |
| Aliskiren 300 mg/Amlodipine 10 mg | EXPERIMENTAL | Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. |
| Aliskiren 300 mg | ACTIVE_COMPARATOR | Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks. |
| Aliskiren / amlodipine | EXPERIMENTAL | Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. |
| Aliskiren / hydrochlorothiazide | EXPERIMENTAL | Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. |
| Amlodipine / hydrochlorothiazide | EXPERIMENTAL | Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. |
| Aliskiren / amlodipine / hydrochlorothiazide | EXPERIMENTAL | Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. |
| Placebo | PLACEBO_COMPARATOR | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 5 of the 5 pills taken were placebos. |
| Aliskiren 150 mg tablet | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Aliskiren 300 mg tablet | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Amlodipine 5 mg capsule | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Amlodipine 10 mg capsule | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg |
| Aliskiren/amlodipine 150/5 mg tablet | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Aliskiren/amlodipine 150/10 mg tablet | EXPERIMENTAL | 150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Aliskiren/amlodipine 300/5 mg tablet | EXPERIMENTAL | Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Aliskiren/amlodipine 300/10 mg tablet | EXPERIMENTAL | 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. |
| Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) | EXPERIMENTAL | - |
| Aliskiren (300 mg) | ACTIVE_COMPARATOR | - |
| Aliskiren 75 mg | EXPERIMENTAL | - |
| Aliskiren 150 mg | EXPERIMENTAL | - |
| Ramipril 5 mg | ACTIVE_COMPARATOR | Ramipril 5 mg once daily |
| Aliskiren/Amlodipine | EXPERIMENTAL | - |
| Aliskiren/Amlodipine/HCTZ | EXPERIMENTAL | - |
| Core Treatment | EXPERIMENTAL | Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled. |
| Extension Treatment | EXPERIMENTAL | For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg. The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits. |
| Aliskiren-based regimen | EXPERIMENTAL | Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg |
| Ramipril-based regimen | ACTIVE_COMPARATOR | Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg |
| 1 | EXPERIMENTAL | Various sequences of different doses of Aliskiren |
| 2 | EXPERIMENTAL | Various sequences of different doses of Aliskiren plus placebo |
| 3 | EXPERIMENTAL | Various sequences of different doses of Aliskiren |
| 4 | EXPERIMENTAL | Various sequences of different doses of Aliskiren plus placebo |
| Aliskiren and Valsartan | EXPERIMENTAL | - |
| Telmisartan and Ramipril | ACTIVE_COMPARATOR | - |
| Valsartan | ACTIVE_COMPARATOR | For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days). |
| Fed Group | ACTIVE_COMPARATOR | - |
| Fasted group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Aliskiren | DRUG | Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg |
| Enalapril | DRUG | Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg |
| Aliskiren (6.25/12.5/25 mg) | DRUG | Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren. |
| Aliskiren (37.5/75/150 mg) | DRUG | Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren. |
| Aliskiren (150/300/600 mg) | DRUG | Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren. |
| Candesartan+HCTZ - Phase 1 | DRUG | 4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am. |
| Aliskiren+HCTZ - Phase 2 | DRUG | Patients with uncontrolled mean sitting diastolic blood pressure (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am. |
| Aliskiren+HCTZ+amlodipine - Phase 3 | DRUG | The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg in a single tablet plus an amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am. |
| Amlodipine | DRUG | Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily. |
| hydrochlorothiazide | DRUG | Hydrochlorothiazide 12.5 mg capsules were taken orally once daily |
| Aliskiren 300 mg | DRUG | Aliskiren 300 mg tablet taken orally once a day with a glass of water. |
| Aliskiren/Amlodipine 300/5 mg | DRUG | Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. |
| Aliskiren/Amlodipine 300/10 mg | DRUG | Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. |
| Placebo to Aliskiren | DRUG | Placebo to Aliskiren tablet taken orally once a day. |
| Placebo to Aliskiren/Amlodipine | DRUG | Placebo to Aliskiren/Amlodipine taken orally once a day. |
| Hydrochlorothiazide (HCTZ) | DRUG | 12.5 and 25 mg capsules |
| Placebo | DRUG | tablet |
| Aliskiren 150 mg tablet | DRUG | - |
| Aliskiren 300 mg tablet | DRUG | - |
| Amlodipine 5 mg capsule | DRUG | - |
| Amlodipine 10 mg capsule | DRUG | - |
| Aliskiren/amlodipine 150/5 mg tablet | DRUG | - |
| Aliskiren/amlodipine 150/10 mg tablet | DRUG | - |
| Aliskiren/amlodipine 300/5 mg tablet | DRUG | - |
| Aliskiren/amlodipine 300/10 mg tablet | DRUG | - |
| Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) | DRUG | During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. |
| Aliskiren (300 mg) | DRUG | During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg. |
| Aliskiren 75 mg | DRUG | Aliskiren 75 mg tablet taken once daily in the morning with a light meal. |
| Aliskiren 150 mg | DRUG | Aliskiren 150 mg tablet taken once daily in the morning with a light meal. |
| Ramipril | DRUG | comparator |
| Aliskiren/HCTZ | DRUG | - |
| Valsartan | DRUG | Valsartan 320 mg |
| Aliskiren plus placebo | DRUG | - |
| Aliskiren/ Valsartan | DRUG | - |
| Telmisartan/ Ramipril | DRUG | - |
| Placebo to valsartan | DRUG | Placebo to valsartan was supplied in capsules matching valsartan 160 mg. |
Inclusion Criteria: * msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365 * Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365 * Must be able to swallow minitablets...