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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01237223 | Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension | PHASE3 | COMPLETED | 1,342 | — | — | Oct 1, 2010 | May 1, 2011 | Jun 13, 2012 | 11 | Japan |
| NCT01113047 | Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine | PHASE3 | COMPLETED | 347 | — | — | May 1, 2010 | - | Dec 6, 2013 | 1 | Germany |
| NCT00667719 | A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension | PHASE3 | COMPLETED | 564 | — | — | Jun 5, 2008 | Oct 5, 2009 | Jun 7, 2021 | 8 | United States, Belgium +6 |
| NCT00343551 | Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension. | PHASE3 | COMPLETED | 654 | — | — | May 1, 2006 | - | Feb 23, 2017 | 2 | Germany, Switzerland |
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. |
| Aliskiren 150 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
| Amlodipine 2.5 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. |
| Amlodipine 5 mg | ACTIVE_COMPARATOR | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Aliskiren/amlodipine 150/2.5 mg | EXPERIMENTAL | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. |
| Aliskiren/amlodipine 150/5 mg | EXPERIMENTAL | In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. |
| Non responder Olmesartan/Amlodipine | EXPERIMENTAL | Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ |
| Aliskiren/Amlodipine/Hydrochlorothiazide | EXPERIMENTAL | Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning. |
| Name | Type | Description |
|---|---|---|
| Aliskiren/Amlodipine 150/2.5 mg | DRUG | Aliskiren/amlodipine 150/2.5 mg tablet |
| Aliskiren/amlodipine 150/5 mg | DRUG | Aliskiren/amlodipine 150/5 mg tablet |
| Aliskiren 150 mg | DRUG | Aliskiren 150 mg tablet |
| Amlodipine 2.5 mg | DRUG | Amlodipine 2.5 mg capsule |
| Placebo of Aliskiren | DRUG | Aliskiren placebo tablet |
| Placebo of Amlodipine | DRUG | Amlodipine placebo capsule |
| Placebo of Aliskiren/amlodipine 150/2.5 mg | DRUG | Aliskiren/amlodipine 150/2.5 mg placebo tablet |
| Placebo of Aliskiren/amlodipine 150/5 mg | DRUG | Aliskiren/amlodipine 150/5 mg placebo tablet |
| Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ | DRUG | Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg |
| Aliskiren | DRUG | 300 mg tablet |
| Amlodipine | DRUG | 5 mg tablet |
| Hydrochlorothiazide | DRUG | 12.5 mg and 25 mg capsule |
Inclusion Criteria: * Patients with essential hypertension (msDBP ≥ 95 mmHg and \< 110 mmHg and msSBP ≥140 mmHg ) * Outpatients Exclusion Criteria: * Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg) * History of allergy or hypersensitivity to renin inhibitors, calcium channel blocker...