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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00651287
First received: March 30, 2008
Last updated: April 7, 2008
Last verified: March 2008
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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
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 Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Quinapril Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013