Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women

NCT ID: NCT00147524

Last Updated: 2007-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-05-31

Brief Summary

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ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.

Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.

Detailed Description

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Conditions

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Menopause Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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quinapril

Intervention Type DRUG

Laser Doppler imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pathological baseline FMD (\< 5%) at screening
* women in post-menopause at least for 2 years (post-menopausal defined as having amenorrhea for Å' 2 years)
* mild or moderate hypertension (BP \> 140/90 mmHg)

Exclusion Criteria

* uncontrolled severe hypertension (BP \> 180/110 mmHg)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hódmezővásárhely, Csongrád megye, Hungary

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Mátészalka, , Hungary

Site Status

Pfizer Investigational Site

Szeged, , Hungary

Site Status

Pfizer Investigational Site

Szombathely, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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A9061010

Identifier Type: -

Identifier Source: org_study_id