NCT00651287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

April 10, 2008

Status Verified

March 1, 2008

First QC Date

March 30, 2008

Last Update Submit

April 7, 2008

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

quinapril 20 mg

ACTIVE COMPARATOR
Drug: quinapril 20 mg

quinapril 20 mg+hydrochlorothiazide 12.5 mg

ACTIVE COMPARATOR
Drug: quinapril 20 mg plus hydrochlorothiazide 12.5 mg

quinapril 40 mg

ACTIVE COMPARATOR
Drug: quinapril 40 mg

Interventions

quinapril 20 mgDRUG

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
quinapril 20 mg plus hydrochlorothiazide 12.5 mgDRUG

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 20 mg+hydrochlorothiazide 12.5 mg
quinapril 40 mgDRUG

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

quinapril 40 mg

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Cerrahpaşa, Istanbul, 34300, Turkey (Türkiye)

Location

Pfizer Investigational Site

Diyarbak R, 21280, Turkey (Türkiye)

Location

Pfizer Investigational Site

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

QuinaprilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazides

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 2, 2008

Study Start

December 1, 2002

Study Completion

June 1, 2004

Last Updated

April 10, 2008

Record last verified: 2008-03

Locations

TU(2)