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  Drug: Laser Doppler imaging	Phase IV

Further Study Details: 

Primary Outcomes: 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.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.
Expected Total Enrollment:  70

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Female

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)

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A9061010
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147524
Health Authority: Hungary: National Institute of Pharmacy
ClinicalTrials.gov processed this record on 2005-09-13