A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives
NCT ID: NCT00825188
Last Updated: 2018-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
10 participants
INTERVENTIONAL
2009-01-31
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
NCT00498433
Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
NCT00170950
Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
NCT00242814
Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
NCT00542269
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
NCT00139555
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
eplerenone
eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
eplerenone
Eplerenone 25-50mg daily x 8 weeks
eplerenone
eplerenone 25- 50 mg daily for 8 weeks
amlodipine
amlodipine 5-10mg daily for 8 weeks
amlodipine
Amlodipine 5-10mg daily times 8 weeks
eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
eplerenone
eplerenone 25- 50 mg daily for 8 weeks
amlodipine
amlodipine 5-10mg daily for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eplerenone, amlodipine
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
eplerenone
Eplerenone 25-50mg daily x 8 weeks
eplerenone
eplerenone 25- 50 mg daily for 8 weeks
amlodipine
amlodipine 5-10mg daily for 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women must be post menopausal
Exclusion Criteria
* 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
21 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Mississippi Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marion Wofford
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marion Wofford, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Mississippi Clinical Research Program
Jackson, Mississippi, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-0035
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.