Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women
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Purpose
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 Procedure: Laser Doppler imaging |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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.
- 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.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2003 |
| Study Completion Date: | May 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | 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:
- uncontrolled severe hypertension (BP > 180/110 mmHg)
Contacts and Locations| Hungary | |
| 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 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00147524 History of Changes |
| Other Study ID Numbers: | A9061010 |
| Study First Received: | September 2, 2005 |
| Last Updated: | April 26, 2007 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Quinapril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013