Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

698

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

November 30, 2007

Study Completion Date

November 30, 2007

Conditions
Hypertension
Interventions
DRUG

Valsartan/amlodipine 80/5 mg

1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

DRUG

Amlodipine 5 mg

1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Trial Locations (12)

100029

China-Japan Friendship Hospital, Beijing

100044

People's hospital affiliated Beijing University, Beijing

200025

Institute of Hypertension, Ruijin Hospital, Shanghai

200032

Zhongshan hospital affiliated Fudan University, Shanghai

200233

The sixth people's hospital of Shanghai, Shanghai

330006

The second hospital affiliated Jiangxi medical school, Nanchang

350001

Union hospital affiliated Fujian medical University, Fuzhou

350005

The first hospital affiliated Fujian medical University, Fuzhou

400038

The first hospital affiliated the third military Medical University, Chongqing

400042

The third hospital affiliated the third military Medical University, Chongqing

410003

The third Xiangya hospital of central south University, Changsha

710061

The first hospital affiliated school of medical of Xi'an Jiaotong University, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY