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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: quinapril 20 mg
* Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg
* Drug: quinapril 40 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quinapril 20 mg<br> | Drug: quinapril 20 mg<br>* 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<br>|
| Active Comparator: quinapril 20 mg+hydrochlorothiazide 12.5 mg<br> | Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg<br>* 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<br>|
| Active Comparator: quinapril 40 mg<br> | Drug: quinapril 40 mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease in diastolic and systolic BP measurements at Week 6 and at Week 12 compared to baseline |  | 12 weeks | 
| Change in heart rate at Week 6 and at Week 12 compared to baseline |  | 12 weeks | 
| Adverse events were recorded throughout the study |  | 12 weeks |