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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00778921 | Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone | PHASE3 | COMPLETED | 847 | — | — | Oct 1, 2008 | Jun 1, 2009 | Oct 27, 2016 | 7 | Argentina, Germany +5 |
| NCT00219141 | Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension | PHASE3 | COMPLETED | 460 | — | — | Oct 1, 2005 | Nov 1, 2007 | May 26, 2011 | 9 | United States, Argentina +7 |
Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.
| Arm | Type | Description |
|---|---|---|
| Amlodipine 10 mg | EXPERIMENTAL | Amlodipine 10 mg |
| Aliskiren/Amlodipine 150/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 150/10 mg |
| Aliskiren/Amlodipine 300/10 mg | EXPERIMENTAL | Aliskiren/Amlodipine 300/10 mg |
| Aliskiren 300 mg | EXPERIMENTAL | Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan placebo. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan placebo. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Losartan 100 mg | ACTIVE_COMPARATOR | Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg placebo and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Aliskiren/losartan 300/100 mg | EXPERIMENTAL | Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks. In order to adequately blind the study, patients were required to take a total of 2 tablets and 1 capsule of study medication or placebo per day. In the first 2 weeks, patients took 1 tablet of aliskiren 150 mg, 1 tablet of aliskiren 150 mg placebo, and 1 capsule of losartan 50 mg. In the remaining 34 weeks, patients took 2 tablets of aliskiren 150 mg and 1 capsule of losartan 100 mg. Each dose was to be taken by mouth with water at approximately 8:00 AM, except on the morning of study visit when the dose was taken after all procedures and assessments had been completed. |
| Name | Type | Description |
|---|---|---|
| Amlodipine 10 mg | DRUG | Amlodipine 10 mg |
| Aliskiren 150 | DRUG | Aliskiren/Amlodipine 150/10 mg |
| Amlodipine 300 | DRUG | Aliskiren/Amlodipine 300/10 mg |
| Aliskiren 150/300 mg | DRUG | Aliskiren 150 mg tablets |
| Losartan 50/100 mg | DRUG | Losartan 50 or 100 mg capsules |
| Aliskiren placebo | DRUG | Aliskiren 150 mg placebo tablet |
| Losartan 50/100 mg placebo | DRUG | Losartan 50/100 mg placebo capsules |
Inclusion Criteria: * Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP ≥ 95 mmHg and \< 110 mmHg at Visits 1 and 2 * Patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a m...