An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

PHASE3CompletedINTERVENTIONAL
Enrollment

556

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Hypertension
Interventions
DRUG

Aliskiren

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

DRUG

Amlodipine

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

DRUG

Hydrochlorothiazide

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Trial Locations (8)

Unknown

Investigative Site, Santa Fe

Investigator Site, Investigative Site

Investigative Center, Investigative Center

Investigative Site, Investigative Site

Investigative Center, Investigative Center

Investigative Site, Investigative Site

Investigative Site, Investigative Site

Investigative Site, Investigative Site

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00402103 - An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure | Biotech Hunter | Biotech Hunter