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

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Pfizer

Status and phase

Completed
Phase 4

Conditions

Hypertension
Menopause

Treatments

Procedure: Laser Doppler imaging
Drug: quinapril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147524
A9061010

Details and patient eligibility

About

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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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