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Completed

NCT Number: NCT00651287

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Cerrahpaşa, Istanbul, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quinapril 20 mg

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 plus hydrochlorothiazide 12.5 mg

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

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

Primary outcomes

  1. 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 outcomes

  1. Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline

    Time frame: 12 weeks

  2. Change in heart rate at Week 6 and at Week 12 compared to baseline

    Time frame: 12 weeks

  3. Adverse events were recorded throughout the study

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Apr 2, 2008
Registry last updated
Apr 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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