drugset / Trial / NCT01237223
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
RandomizedFactorialDouble-blindTreatment
Summary
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aliskiren | Small molecule | 150 mg | — |
| Comparator | Amlodipine | Other / unclassified | 2.5 mg | — |
| Comparator | Amlodipine | Other / unclassified | 5 mg | — |