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...
Date First Received: August 21, 2006
Last Updated: July 6, 2007
Verified by: Novartis, March 2007
Clinical Trial Phase: Phase 3 | Start Date: July 2006
Overall Status: Completed
Estimated Enrollment: 296
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Benazepril plus hydrochlorothiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Change in diastolic blood pressure from baseline to week 8
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Principal Investigator Novartis
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367094
Study ID Number: CLHT344ACN01
ClinicalTrials.gov Identifier: NCT00367094
Health Authority: China: Ministry of Health
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
