NCT00942994

Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension

An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/Amlodipine	Amlodipine capsule (5 mg) Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg)
DRUG	Aliskiren/Amlodipine and Hydrochlorothiazide (HCTZ)	Aliskiren/Amlodipine tablets (150/5 mg, 300/5 mg, 300/10 mg) HCTZ capsule (12.5 mg, 25mg)

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-03-01
• First posted: 2009-07-21
• Last updated: 2011-06-08
• Results posted: 2011-04-27

Locations

5 sites across 1 country: United States