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

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Moderate to Severe Hypertension
Interventions
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.

Trial Locations (6)

Unknown

Investigative Site, Berlin

Investigative Site, Manila

Investigative Site, Bucharest

Investigative Site, Moscow

Investigative Site, Singapore

Investigative Site, Madrid

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY