Effectiveness of EXforge® and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients

Condition(s) targeted: Hypertension

Intervention: Valsartan/Amlodipine 80/5mg single pill combination (Drug); Nifedipine GITS (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

This study is to demonstrate that valsartan/amlodipine 80/5 mg has superior efficacy compared with nifedipine 30mg alone in reducing the mean sitting diastolic blood pressure (MSDBP) and mean sitting systolic blood pressure (MSSBP) from baseline in patients with mild to moderate hypertension not adequately controlled with monotherapy.

Official title: A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of EXforge® and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Measure: The changes of MSSBP/MSDBP achieved at the study end point

Secondary outcome:

The proportion of patients in whom BP control was achieved at the study end point. BP control was defined as mean sitting BP <140/90 mm Hg in nondiabetic patients and <130/80 mm Hg in diabetic patients

Changes of ABPM achieves at end of the study

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female adult outpatients had uncontrolled hypertension at both screening and

randomization despite current antihypertensive monotherapy

Exclusion Criteria:

- Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP)

level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.

- Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated

hemoglobin >8. 0%) .

- Patients had evidence of hepatic disease or renal impairment。

- Other exclusion criteria included evidence of secondary hypertension or history of

CVD.

- Women who were pregnant, nursing, or of childbearing potential and not using

acceptable contraception.

- Other protocol-defined inclusion/exclusion criteria may apply

Novartis Pharmaceuticals, Beijing, China; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-6500

Starting date: May 2010
Last updated: August 30, 2010