Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Eplerenone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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 outcome: Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Montreal, Quebec H2W 1R7, Canada
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: October 2003
Ending date: May 2006
Last updated: April 14, 2008
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