Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT

This study has been completed.

First Received: September 2, 2005 Last Updated: April 14, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147563

Purpose

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	Intervention	Phase
Hypertension	Drug: Eplerenone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atenolol

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Estimated Enrollment:	34
Study Start Date:	October 2003
Estimated Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147563

Locations

Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H2W 1R7

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Savoia C, Touyz RM, Amiri F, Schiffrin EL. Selective mineralocorticoid receptor blocker eplerenone reduces resistance artery stiffness in hypertensive patients. Hypertension. 2008 Feb;51(2):432-9. Epub 2008 Jan 14.

Study ID Numbers:	EPLA-0501-077, A6141016
Study First Received:	September 2, 2005
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00147563 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Vascular Diseases
Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on February 09, 2010