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TerminatedNCT00825188Updated May 29, 2018

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

An interventional study of eplerenone, amlodipine and eplerenone in Obesity and Hypertension, sponsored by University of Mississippi Medical Center. Terminated at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-05-29.

Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
funding to complete was inadequate
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
21 Years to 100 Years
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Obesity
  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 10 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    eplerenone

    Drug: eplerenone, amlodipine · Drug: eplerenone · Drug: amlodipine

  • Active comparator
    amlodipine

    Amlodipine 5-10mg daily times 8 weeks

    Drug: eplerenone, amlodipine · Drug: eplerenone · Drug: amlodipine

Interventions

  • Drugeplerenone, amlodipine

    Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks

    Also known as: Inspra, Norvasc

  • Drugeplerenone

    Eplerenone 25-50mg daily x 8 weeks

    Also known as: Inspra

  • Drugeplerenone

    eplerenone 25- 50 mg daily for 8 weeks

    Also known as: Inspra, Norvasc

  • Drugamlodipine

    amlodipine 5-10mg daily for 8 weeks

    Also known as: Norvasc

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What researchers measure

Primary outcomes

  1. Basal metabolic rate

    Time frame: Pre and post treatment

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Study locations

1 site
  • The University of Mississippi Clinical Research Program
    Jackson, Mississippi 39216, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00825188
Lead sponsor
University of Mississippi Medical Center
Responsible party
Marion Wofford (Professor, University of Mississippi Medical Center) — Principal investigator
First posted
Jan 19, 2009
Start date
Jan 2009
Primary completion
Mar 2014
Completion
Mar 2014
Last update
May 29, 2018

Study contacts

Marion Wofford, MD
principal investigator · University of Mississippi Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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