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Completed

NCT Number: NCT00147524

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

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.

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Key information

Conditions

Menopause Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Hódmezővásárhely, Csongrád megye, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quinapril

Drug

Laser Doppler imaging

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Sep 7, 2005
Registry last updated
Apr 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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