Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00147563
Collaborator
(none)
34
1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Oct 1, 2003
Actual Primary Completion Date
:
May 1, 2006
Outcome Measures
Primary Outcome 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 Outcome Measures
- Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods []
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Montreal | Quebec | Canada | H2W 1R7 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00147563
Other Study ID Numbers:
- EPLA-0501-077
- A6141016
- NCT00260845
First Posted:
Sep 7, 2005
Last Update Posted:
Apr 15, 2008
Last Verified:
May 1, 2007