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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00841672 | Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension | PHASE3 | COMPLETED | 485 | — | — | Jan 1, 2009 | Sep 1, 2009 | Jul 12, 2011 | 6 | Germany, Philippines +4 |
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
| Arm | Type | Description |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | EXPERIMENTAL | Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg. |
| Amlodipine 10 mg capsule | ACTIVE_COMPARATOR | Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg. |
| Name | Type | Description |
|---|---|---|
| Aliskiren/amlodipine 300/10 mg tablet | DRUG | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was 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 two tablets and one capsule of study medication per day throughout the study. |
| Amlodipine 10 mg capsule | DRUG | Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was 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 two tablets and one capsule of study medication per day throughout the study. |
Inclusion Criteria: * Outpatients ≥ 18 years of age * Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2 Exclusion Criteria: * Mild to moderate hypertension * Pregnant or nursing (lactating) women * Women of child-bearing potential...