A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg; Drug: quinapril 20 mg; Drug: quinapril 40 mg

• Registration Number: NCT00651287
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine the response rate for the therapeutic goal (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week 6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20 mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2004-06
• Status Verified: 2008-03
• Study First Submitted: 2008-03-30
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• A clinical diagnosis of mild to moderate primary hypertension ("Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 6th report" Stage I or II)
• Sitting diastolic blood pressure between 90 mmHg and 109 mmHg and systolic blood pressure between 140 mmHg and 179 mmHg at the end of the no-treatment run-in period

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Exclusion Criteria

• Subjects with secondary hypertension
• Subjects with serious cardiac disease (including myocardial infarction in the last 3 months or decompensated heart failure)
• Subjects who do not accept to stop using any other antihypertensive treatment during the run-in period and the treatment period of the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quinapril 20 mg+hydrochlorothiazide 12.5 mg	quinapril 20 mg plus hydrochlorothiazide 12.5 mg	-
quinapril 20 mg	quinapril 20 mg	-
quinapril 40 mg	quinapril 40 mg	-

Primary Outcome Measures

Name	Time	Method
Response rate for the therapeutic goal (at Week 6 for 20mg quinapril and at Week 12 for 40mg quinapril and 20mg quinapril plus 12.5mg hydrochlorothiazide)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline	12 weeks
Change in heart rate at Week 6 and at Week 12 compared to baseline	12 weeks
Adverse events were recorded throughout the study	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site