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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00651287

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 IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Quinapril hydrochloride Quinapril

U.S. FDA Resources

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
quinapril 20 mg: Active Comparator	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
quinapril 20 mg+hydrochlorothiazide 12.5 mg: Active Comparator	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
quinapril 40 mg: Active Comparator	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

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

Locations

Turkey
Pfizer Investigational Site
DIYARBAK R, Turkey, 21280
Turkey, ANKARA
Pfizer Investigational Site
Unknown, ANKARA, Turkey
Turkey, BURSA
Pfizer Investigational Site
Unknown, BURSA, Turkey
Turkey, ICEL
Pfizer Investigational Site
Unknown, ICEL, Turkey
Turkey, ISTANBUL
Pfizer Investigational Site
CERRAHPASA, ISTANBUL, Turkey, 34300
Pfizer Investigational Site
Unknown, ISTANBUL, Turkey
Turkey, KONYA
Pfizer Investigational Site
Unknown, KONYA, Turkey
Turkey, MANISA
Pfizer Investigational Site
Unknown, MANISA, Turkey
Turkey, SIVAS
Pfizer Investigational Site
Unknown, SIVAS, Turkey
Turkey, TRABZON
Pfizer Investigational Site
Unknown, TRABZON, Turkey

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Quinapril
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors

Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Quinapril
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009