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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147563
First received: September 2, 2005
Last updated: April 14, 2008
Last verified: May 2007

September 2, 2005
April 14, 2008
October 2003
May 2006   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00147563 on ClinicalTrials.gov Archive Site
Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods
Same as current
Not Provided
Not Provided
 
Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Eplerenone
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
Not Provided
May 2006   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00147563
EPLA-0501-077, A6141016
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP