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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: quinapril 20 mg; Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg; Drug: quinapril 40 mg

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• • • Pfizer Investigational Site
• Turkey
  • Diyarbak R, Turkey, 21280
    • Pfizer Investigational Site
  • Istanbul
    • Cerrahpasa, Istanbul, Turkey, 34300
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: quinapril 20 mg	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
Active Comparator: quinapril 20 mg+hydrochlorothiazide 12.5 mg	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
Active Comparator: quinapril 40 mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: March 30, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 2, 2008

Study Record Updates

• Last Update Posted (Estimate): April 10, 2008
• Last Update Submitted That Met QC Criteria: April 7, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Quinapril
• Other Study ID Numbers: A9061007