Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Hypertension
Interventions
DRUG

Amlodipine

Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.

DRUG

Olmesartan medoxomil

Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.

DRUG

Amlodipine+valsartan

Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.

DRUG

Hydrochlorothiazide

Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Trial Locations (2)

Unknown

Novartis Investigative Site, , Germany, Schwerin

30 sites in Germany

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY