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

PHASE3CompletedINTERVENTIONAL
Enrollment

818

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Hypertension
Interventions
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.

Trial Locations (9)

Unknown

Investigative site, Estonia

Investigative site, France

Investigative Site, Iceland

Investigative Site, India

Investigative site, Italy

Investigative Site, Lithuania

Investigative Site, Republic of Korea

Investigative Site, Spain

Investigative Site, Venezuela

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY