NCT00797862

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,254 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

Detailed description

This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy. The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning. The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.
DRUG	hydrochlorothiazide	Hydrochlorothiazide 12.5 mg capsules were taken orally once daily
DRUG	Aliskiren	Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-11-25
• Last updated: 2011-10-17
• Results posted: 2011-05-17

Locations

10 sites across 10 countries: Canada, Costa Rica, France, Germany, Greece, Guatemala, South Africa, Switzerland, United Kingdom, Venezuela