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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00651287
First received: March 30, 2008
Last updated: April 7, 2008
Last verified: March 2008

March 30, 2008
April 7, 2008
December 2002
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00651287 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
  • Active Comparator: quinapril 20 mg
    Intervention: Drug: quinapril 20 mg
  • Active Comparator: quinapril 20 mg+hydrochlorothiazide 12.5 mg
    Intervention: Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
  • Active Comparator: quinapril 40 mg
    Intervention: Drug: quinapril 40 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2004
Not Provided

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
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00651287
A9061007
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

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