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
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: quinapril 20 mg
Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
Drug: quinapril 40 mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: December 2002
Study Completion Date: June 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651287

Locations
Turkey
Pfizer Investigational Site
Unknown, Ankara, Turkey
Pfizer Investigational Site
Unknown, Bursa, Turkey
Pfizer Investigational Site
Unknown, Icel, Turkey
Pfizer Investigational Site
Cerrahpasa, Istanbul, Turkey, 34300
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
Pfizer Investigational Site
Diyarbak R, Turkey, 21280
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00651287     History of Changes
Other Study ID Numbers: A9061007
Study First Received: March 30, 2008
Last Updated: April 7, 2008
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Quinapril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014