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 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Hypertension | Drug: eplerenone, amlodipine Drug: eplerenone Drug: amlodipine | Not Applicable |
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:
- 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.
- 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.
- 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.
- Obtain blood pressure measures at all visits.
- Obtain mood ratings at all visits.
- Compare basal metabolic rate, cardiac output and other indices of cardiac performance between treatment groups.
- Compare difference in SBP and DBP between treatment groups.
- Compare differences in plasma insulin, serum electrolytes, plasma renin activity, cortisol and aldosterone concentrations, urinary albumin excretion, and glomerular filtration rate between treatment groups.
- Compare mood rating as well as symptoms of depression and anxiety between treatment groups.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Investigation of Reduction of Blood Pressure and Metabolic Rate in Obese Hypertensive Patients Using Eplerenone: Implications for Treatment of Hypertension and Heart Failure |
Actual Study Start Date : | January 2009 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: eplerenone |
Drug: eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
Other Names:
Drug: eplerenone Eplerenone 25-50mg daily x 8 weeks
Other Name: Inspra Drug: eplerenone eplerenone 25- 50 mg daily for 8 weeks
Other Names:
Drug: amlodipine amlodipine 5-10mg daily for 8 weeks
Other Name: Norvasc |
Active Comparator: amlodipine
Amlodipine 5-10mg daily times 8 weeks
|
Drug: eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
Other Names:
Drug: eplerenone eplerenone 25- 50 mg daily for 8 weeks
Other Names:
Drug: amlodipine amlodipine 5-10mg daily for 8 weeks
Other Name: Norvasc |
- Basal metabolic rate [ Time Frame: Pre and post treatment ]

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Ages Eligible for Study: | 21 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825188
United States, Mississippi | |
The University of Mississippi Clinical Research Program | |
Jackson, Mississippi, United States, 39216 |
Principal Investigator: | Marion Wofford, MD | University of Mississippi Medical Center |
Responsible Party: | Marion Wofford, Professor, University of Mississippi Medical Center |
ClinicalTrials.gov Identifier: | NCT00825188 |
Other Study ID Numbers: |
2008-0035 |
First Posted: | January 19, 2009 Key Record Dates |
Last Update Posted: | May 29, 2018 |
Last Verified: | March 2014 |
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Eplerenone Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Diuretics, Potassium Sparing Diuretics Natriuretic Agents |