Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,474

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Essential Hypertension
Interventions
DRUG

Valsartan + amlodipine 40/2.5 mg

Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 40/5 mg

Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 80/2.5 mg

Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 80/5 mg

Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan 40 mg

Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan 80 mg

Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

DRUG

Amlodipine 5 mg

Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

DRUG

Placebo

4 tablet and 2 capsule placebos taken once daily

Trial Locations (1)

11111

Novartis Pharmaceuticals, Tokyo

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY