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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147524
First received: September 2, 2005
Last updated: April 26, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Menopause
Hypertension
Drug: quinapril
Procedure: Laser Doppler imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.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.

Estimated Enrollment: 70
Study Start Date: October 2003
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147524

Locations
Hungary
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00147524     History of Changes
Other Study ID Numbers: A9061010
Study First Received: September 2, 2005
Last Updated: April 26, 2007
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Quinapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014