Back to resultsCombination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Benazepril plus hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, benazepril, hydrochlorothiazide, fixed combination
Eligibility 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.
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Change in diastolic blood pressure from baseline to week 8
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367094
Brief Title
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, benazepril, hydrochlorothiazide, fixed combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
296 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Benazepril plus hydrochlorothiazide
Primary Outcome Measure Information:
Title
Change in diastolic blood pressure from baseline to week 8
Secondary Outcome Measure Information:
Title
Change in systolic blood pressure from baseline to week 8
Title
Proportion of patients with blood pressure less than 140/90 mmHg at week 8
Title
Ambulant blood pressure monitoring profiles at baseline and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension
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