Official 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”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

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
    Safety Issue?: No

Secondary Measures

• Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in heart rate at Week 6 and at Week 12 compared to baseline
  • Time Frame: 12 weeks
    Safety Issue?: No
• Adverse events were recorded throughout the study
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651287

Study ID Number: A9061007

ClinicalTrials.gov Identifier: NCT00651287

Health Authority: Turkey: Ministry of Health

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting: