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

Tracking Information

First Received Date ^ICMJE

August 21, 2006

Last Updated Date

July 6, 2007

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in diastolic blood pressure from baseline to week 8

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00367094 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Benazepril plus hydrochlorothiazide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

296

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00367094

Responsible Party

Study ID Numbers ^ICMJE

CLHT344ACN01

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP