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

NCT00825188 | Terminated DMC

• 1 other identifier: 2008-0035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypertension

Outcome Measures

Primary Outcomes (1)

• Basal metabolic rate

  Pre and post treatment

Study Arms (2)

eplerenone

ACTIVE COMPARATOR

Drug: eplerenone, amlodipine; Drug: eplerenone; Drug: amlodipine

amlodipine

ACTIVE COMPARATOR

Amlodipine 5-10mg daily times 8 weeks

Drug: eplerenone, amlodipine; Drug: eplerenone; Drug: amlodipine

Interventions

eplerenone, amlodipine DRUG

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

Also known as: Inspra, Norvasc

amlodipine; eplerenone

eplerenone DRUG

Eplerenone 25-50mg daily x 8 weeks

Also known as: Inspra

eplerenone

amlodipine DRUG

amlodipine 5-10mg daily for 8 weeks

Also known as: Norvasc

amlodipine; eplerenone

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

The University of Mississippi Clinical Research Program

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

Eplerenone; Amlodipine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marion Wofford, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 19, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 29, 2018

Record last verified: 2014-03

Locations

US (1)