NCT00777946

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 818 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren 300 mg	Aliskiren 300 mg tablet taken orally once a day with a glass of water.
DRUG	Aliskiren/Amlodipine 300/5 mg	Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.
DRUG	Aliskiren/Amlodipine 300/10 mg	Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.
DRUG	Placebo to Aliskiren	Placebo to Aliskiren tablet taken orally once a day.
DRUG	Placebo to Aliskiren/Amlodipine	Placebo to Aliskiren/Amlodipine taken orally once a day.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-10-22
• Last updated: 2011-07-12
• Results posted: 2011-06-15

Locations

9 sites across 9 countries: Estonia, France, Iceland, India, Italy, Lithuania, South Korea, Spain, Venezuela