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

Tracking Information

First Received Date ^ICMJE

March 30, 2008

Last Updated Date

April 7, 2008

Start Date ^ICMJE

December 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651287 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in heart rate at Week 6 and at Week 12 compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Adverse events were recorded throughout the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: quinapril 20 mg
Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
Drug: quinapril 40 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT ID ^ICMJE

NCT00651287

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A9061007

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP