NCT00841672

Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.

Conditions

• Moderate to Severe Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/amlodipine 300/10 mg tablet	Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.
DRUG	Amlodipine 10 mg capsule	Each dose was taken by mouth with water at approximately 8:00 in the morning with or without food, except on the morning of the next office/clinic visit, when the medication was taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of two tablets and one capsule of study medication per day throughout the study.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-02-11
• Last updated: 2011-07-12
• Results posted: 2011-06-27

Locations

6 sites across 6 countries: Germany, Philippines, Romania, Russia, Singapore, Spain