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CompletedNCT00147524Updated Apr 30, 2007

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

A Phase 4 interventional study of quinapril and Laser Doppler imaging in Menopause and Hypertension, sponsored by Pfizer. Completed at 5 sites in Hungary. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-04-30.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Menopause
  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 70 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • uncontrolled severe hypertension (BP > 180/110 mmHg)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants

Interventions

  • Drugquinapril
  • ProcedureLaser Doppler imaging
06

What researchers measure

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.

07

Study locations

5 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00147524
Lead sponsor
Pfizer
First posted
Sep 7, 2005
Start date
Oct 2003
Completion
May 2005
Last update
Apr 30, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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