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

Condition(s) targeted: Hypertension

Intervention: quinapril 20 mg (Drug); quinapril 20 mg plus hydrochlorothiazide 12.5 mg (Drug); quinapril 40 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

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

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

Adverse events were recorded throughout the study

Minimum age: 19 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Diyarbak R 21280, Turkey

Pfizer Investigational Site, Unknown, Ankara, Turkey

Pfizer Investigational Site, Unknown, Bursa, Turkey

Pfizer Investigational Site, Unknown, Icel, Turkey

Pfizer Investigational Site, Cerrahpasa, Istanbul 34300, Turkey

Pfizer Investigational Site, Unknown, Istanbul, Turkey

Pfizer Investigational Site, Unknown, Konya, Turkey

Pfizer Investigational Site, Unknown, Manisa, Turkey

Pfizer Investigational Site, Unknown, Sivas, Turkey

Pfizer Investigational Site, Unknown, Trabzon, Turkey

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

Starting date: December 2002
Last updated: April 7, 2008