NCT00367094

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P50-P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

July 9, 2007

Status Verified

March 1, 2007

First QC Date

August 21, 2006

Last Update Submit

July 6, 2007

Conditions

Hypertension

Keywords

Hypertension, benazepril, hydrochlorothiazide, fixed combination

Outcome Measures

Primary Outcomes (1)

  • Change in diastolic blood pressure from baseline to week 8

Secondary Outcomes (3)

  • 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

Interventions

Benazepril plus hydrochlorothiazideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients, age 18 or older
  • Given informed consent
  • Diagnosed as having mild to moderate essential hypertension

You may not qualify if:

  • Severe hypertension
  • Significant preexisting cardiovascular and cerebrovascular disease
  • Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II
  • Advanced renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Beijing, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

benazeprilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 22, 2006

Study Start

July 1, 2006

Last Updated

July 9, 2007

Record last verified: 2007-03

Locations

CN(1)