NCT00853957

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/Amlodipine	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
DRUG	Amlodipine	Amlodipine 5 mg titrated to 10mg

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-03-02
• Last updated: 2012-04-30
• Results posted: 2011-01-21

Locations

9 sites across 1 country: United States