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Trial record 36 of 112 for:    EPLERENONE

A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives

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ClinicalTrials.gov Identifier: NCT00825188
Recruitment Status : Terminated (funding to complete was inadequate)
First Posted : January 19, 2009
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Marion Wofford, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE January 16, 2009
First Posted Date  ICMJE January 19, 2009
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE January 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2009)
Basal metabolic rate [ Time Frame: Pre and post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00825188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives
Official Title  ICMJE Investigation of Reduction of Blood Pressure and Metabolic Rate in Obese Hypertensive Patients Using Eplerenone: Implications for Treatment of Hypertension and Heart Failure
Brief Summary Obesity and hypertension are independent risks for congestive heart failure (CHF) and chronic kidney disease. In obesity induced hypertension, the most common cause of human essential hypertension, the potential importance of mineralocorticoid receptor blockade has not been widely investigated. We propose to test the hypothesis that eplerenone reduces metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and microalbuminuria in obese patients. Our specific aims are to assess changes in basal metabolic rate, cardiac and renal function in obese hypertensive subjects treated with eplerenone compared to amlodipine.
Detailed Description

The proposed trial will utilize an open label study design. Patients with hypertension and obesity will be recruited. After a 3-week washout period for patients currently on antihypertensive medication, eligible participants will be assigned to receive 25 mg of eplerenone or 5 mg of amlodipine. After a 4 week period on medication, drug will be advanced to 50 mg of eplerenone or 10 mg of amlodipine for an additional 4 weeks.

Protocol Synopsis:

  1. Recruit 20 study participants with a systolic blood pressure (SBP) between 140 and 160 mmHg and/or a diastolic blood pressure between 90 and 100 mmHg who also have a body mass index > 30-45. If participants are on antihypertensive treatment, they will undergo a 3-week washout period. The study participants will be identified in the Division of Hypertension.
  2. Assign study participants to receive 25 mg of eplerenone or 5 mg of amlodipine per day for 4 weeks. Up-titration to eplerenone 50 mg and amlodipine 10 mg for an additional 4 weeks.
  3. Obtain basal metabolic rate, cardiac output and other indices of cardiac performance, cognitive abilities, and rating of depression and anxiety symptoms at baseline and after 8 weeks of treatment.
  4. Obtain blood pressure measures at all visits.
  5. Obtain mood ratings at all visits.
  6. Compare basal metabolic rate, cardiac output and other indices of cardiac performance between treatment groups.
  7. Compare difference in SBP and DBP between treatment groups.
  8. Compare differences in plasma insulin, serum electrolytes, plasma renin activity, cortisol and aldosterone concentrations, urinary albumin excretion, and glomerular filtration rate between treatment groups.
  9. Compare mood rating as well as symptoms of depression and anxiety between treatment groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Hypertension
Intervention  ICMJE
  • Drug: eplerenone, amlodipine
    Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
    Other Names:
    • Inspra
    • Norvasc
  • Drug: eplerenone
    Eplerenone 25-50mg daily x 8 weeks
    Other Name: Inspra
  • Drug: eplerenone
    eplerenone 25- 50 mg daily for 8 weeks
    Other Names:
    • Inspra
    • Norvasc
  • Drug: amlodipine
    amlodipine 5-10mg daily for 8 weeks
    Other Name: Norvasc
Study Arms  ICMJE
  • Active Comparator: eplerenone
    Interventions:
    • Drug: eplerenone, amlodipine
    • Drug: eplerenone
    • Drug: eplerenone
    • Drug: amlodipine
  • Active Comparator: amlodipine
    Amlodipine 5-10mg daily times 8 weeks
    Interventions:
    • Drug: eplerenone, amlodipine
    • Drug: eplerenone
    • Drug: amlodipine
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2009)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Systolic blood pressure (SBP) between 140 and 160 mmHg and/or a diastolic blood pressure between 90 and 100 mmHg who also have a body mass index > 30-45.
  • Women must be post menopausal

Exclusion Criteria:

  • Women of child bearing potential
  • BMI less than 30 or greater than 45
  • A creatinine > 1.8 for females and > 2.0 for males
  • Type 1 or type 2 diabetes
  • Current evidence of alcohol or drug abuse problems
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00825188
Other Study ID Numbers  ICMJE 2008-0035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marion Wofford, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marion Wofford, MD University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date March 2014

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