drugset / Trial / NCT01237223

Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

NCT01237223

Phase 3 Completed 1342 enrolled Novartis
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

EvaluationDrugModalityDoseRoute
Comparator Aliskiren Small molecule 150 mg
Comparator Amlodipine Other / unclassified 2.5 mg
Comparator Amlodipine Other / unclassified 5 mg