To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol...
Date First Received: September 2, 2005
Last Updated: April 14, 2008
Verified by: Pfizer, May 2007
Clinical Trial Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 34
Brief Summary
Official Title: “A Double-Blind, Parallel Design Study to Compare the Effectiveness of Eplerenone Versus Atenolol in Reversing the Remodeling of Resistance Arteries in Subjects With Mild to Moderate Primary Hypertension”
Condition Keyword(s):
Intervention(s):
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: May 2006
Intervention(s) in this Clinical Trial
- Drug: Eplerenone
Outcome Measures for this Clinical Trial
Primary Measures
- The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy.
Secondary Measures
- Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Pt with essential hypertension who have never been treated or untreated within the previous 6 months
Exclusion Criteria:
- History of Malignant Hypertension
- Sitting diastolic blood pressure > 115mmHg or sitting Systolic blood pressure >
- 200mmHg
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147563
Study ID Number: EPLA-0501-077
ClinicalTrials.gov Identifier: NCT00147563
Health Authority: United States: Food and Drug Administration
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