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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147524
• Other study ID #: A9061010
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: April 26, 2007
• Start date: October 2003
• Est. completion date: May 2005

Study information

• Verified date: April 2007
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Menopause

Intervention

Drug:
• quinapril

Procedure:
• Laser Doppler imaging

Locations

Country	Name	City	State
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Hodmezovasarhely	Csongrad
Hungary	Pfizer Investigational Site	Mateszalka
Hungary	Pfizer Investigational Site	Szeged
Hungary	Pfizer Investigational Site	Szombathely

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.