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

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ClinicalTrials.gov Identifier: NCT00367094
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : July 9, 2007
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Benazepril plus hydrochlorothiazide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in diastolic blood pressure from baseline to week 8

Secondary Outcome Measures :
  1. Change in systolic blood pressure from baseline to week 8
  2. Proportion of patients with blood pressure less than 140/90 mmHg at week 8
  3. Ambulant blood pressure monitoring profiles at baseline and week 8


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367094


Locations
China
Novartis
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00367094     History of Changes
Other Study ID Numbers: CLHT344ACN01
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: July 9, 2007
Last Verified: March 2007

Keywords provided by Novartis:
Hypertension, benazepril, hydrochlorothiazide, fixed combination

Additional relevant MeSH terms:
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Benazepril
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors