Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Benazepril plus hydrochlorothiazide (Drug)
Phase: Phase 3
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
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.
- Male or female patients, age 18 or older
- Given informed consent
- Diagnosed as having mild to moderate essential hypertension
- 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.
Locations and Contacts
Novartis, Beijing, China
Starting date: July 2006
Last updated: July 6, 2007