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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147524
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : April 30, 2007
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Menopause Hypertension Drug: quinapril Procedure: Laser Doppler imaging Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label (Non-Comparative) Study To Evaluate Changes In Flow Mediated Dilatation During And After A 6 Months Treatment Period With Step By Step Increased Doses With Quinapril Therapy In Post-Menopausal Women With Mild Or Moderate Hypertension
Study Start Date : October 2003
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Primary Outcome Measures :
  1. To evaluate the effect of 10, 20 and 40 mg daily sequential quinapril doses in a 3 x 8 weeks treatment period as changes to baseline pathological FMD.

Secondary Outcome Measures :
  1. 1.In a subgroup of about 30 patients to assess microvascular vasomotor function by laser Doppler (LD) techniques. For all patients: 2.Evaluation of changes of BP parameters. 3.Changes in PAI-1 level. 4.Collect safety data.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147524

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Pfizer Investigational Site
Hodmezovasarhely, Csongrad, Hungary
Pfizer Investigational Site
Budapest, Hungary
Pfizer Investigational Site
Mateszalka, Hungary
Pfizer Investigational Site
Szeged, Hungary
Pfizer Investigational Site
Szombathely, Hungary
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Layout table for additonal information Identifier: NCT00147524    
Other Study ID Numbers: A9061010
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: April 30, 2007
Last Verified: April 2007
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents