Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension

Condition(s) targeted: Hypertension

Intervention: Benazepril plus hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Principal Investigator, Affiliation: Novartis

This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.

Official title: Efficacy and Safety of the Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Benazepril

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in diastolic blood pressure from baseline to week 8

Secondary outcome:

Change in systolic blood pressure from baseline to week 8

Proportion of patients with blood pressure less than 140/90 mmHg at week 8

Ambulant blood pressure monitoring profiles at baseline and week 8

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients, age 18 or older

- Given informed consent

- Diagnosed as having mild to moderate essential hypertension

Exclusion Criteria:

- Severe hypertension

- Significant preexisting cardiovascular and cerebrovascular disease

- Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II

- Advanced renal impairment

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis, Beijing, China

Starting date: July 2006
Last updated: July 6, 2007