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

NCT00147563

Last updated date
Study Location
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pt with essential hypertension who have never been treated or untreated within the previous 6 months

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of Malignant Hypertension


- Sitting diastolic blood pressure > 115mmHg or sitting Systolic blood pressure >
200mmHg

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Advanced Information
Descriptive Information
Brief Title  ICMJE Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Eplerenone
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1161/HYPERTENSIONAHA.107.103267. Epub 2008 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 2, 2005)
34
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147563
Other Study ID Numbers  ICMJE EPLA-0501-077
A6141016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2007

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