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

Overview

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.

Full Title of Study: “A 12-Week Open-Label, Uncontrolled Multicenter Study to Assess the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Subjects With Mild to Moderate Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: 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
  • 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
  • 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

Arms, Groups and Cohorts

  • Active Comparator: quinapril 20 mg
  • Active Comparator: quinapril 20 mg+hydrochlorothiazide 12.5 mg
  • Active Comparator: quinapril 40 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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)
    • Time Frame: 12 weeks

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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