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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651287

Enrollment

200

Registered

2008-04-02

Start date

2002-12-31

Completion date

2004-06-30

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DRUGquinapril 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

DRUGquinapril 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

DRUGquinapril 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

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026