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

NCT ID: NCT00651287

Last Updated: 2008-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-06-30

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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quinapril 20 mg

Group Type ACTIVE_COMPARATOR

quinapril 20 mg

Intervention Type DRUG

Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks

quinapril 20 mg+hydrochlorothiazide 12.5 mg

Group Type ACTIVE_COMPARATOR

quinapril 20 mg plus hydrochlorothiazide 12.5 mg

Intervention Type DRUG

Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks

quinapril 40 mg

Group Type ACTIVE_COMPARATOR

quinapril 40 mg

Intervention Type DRUG

Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks

Interventions

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quinapril 20 mg

Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks

Intervention Type DRUG

quinapril 20 mg plus hydrochlorothiazide 12.5 mg

Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks

Intervention Type DRUG

quinapril 40 mg

Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cerrahpaşa, Istanbul, Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Diyarbak R, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9061007&StudyName=A%20Study%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Quinapril%20or%20Quinapril%20Plus%20Hydrochlorothiazide%20in%20Patients%20with%20Mild%20to%20Moderate%20Hyper

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Other Identifiers

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A9061007

Identifier Type: -

Identifier Source: org_study_id