NCT01237223

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

An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,342 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/Amlodipine 150/2.5 mg	Aliskiren/amlodipine 150/2.5 mg tablet
DRUG	Aliskiren/amlodipine 150/5 mg	Aliskiren/amlodipine 150/5 mg tablet
DRUG	Aliskiren 150 mg	Aliskiren 150 mg tablet
DRUG	Amlodipine 2.5 mg	Amlodipine 2.5 mg capsule
DRUG	Placebo of Aliskiren	Aliskiren placebo tablet
DRUG	Placebo of Amlodipine	Amlodipine placebo capsule
DRUG	Placebo of Aliskiren/amlodipine 150/2.5 mg	Aliskiren/amlodipine 150/2.5 mg placebo tablet
DRUG	Placebo of Aliskiren/amlodipine 150/5 mg	Aliskiren/amlodipine 150/5 mg placebo tablet

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-11-09
• Last updated: 2012-06-13
• Results posted: 2012-06-13

Locations

11 sites across 1 country: Japan