ObesityNCT00825188
A Study of the Effects of Eplerenone and Amlodipine on Blood Pressure and Basal Metabolic Rate in Obese Hypertensives
A study testing eplerenone, amlodipine, eplerenone and amlodipine in people with Obesity and Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- eplerenone, amlodipine, eplerenone and amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Mississippi Clinical Research Program
Jackson, Mississippi, 39216
About this study
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
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:
- 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.
- Conditions
- Obesity, Hypertension
- Being tested
- eplerenone, amlodipine, eplerenone, amlodipine
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eplerenone, amlodipineDrug
Also called Inspra, Norvasc
Eplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks
eplerenoneDrug
Also called Inspra
Eplerenone 25-50mg daily x 8 weeks
eplerenoneDrug
Also called Inspra, Norvasc
eplerenone 25- 50 mg daily for 8 weeks
amlodipineDrug
Also called Norvasc
amlodipine 5-10mg daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| eplerenone | Active comparator | Not described Receives: Drug: eplerenone, amlodipine; Drug: eplerenone; Drug: amlodipine |
| amlodipine | Active comparator | Amlodipine 5-10mg daily times 8 weeks Receives: Drug: eplerenone, amlodipine; Drug: eplerenone; Drug: amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal metabolic rate
Measured: Pre and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: funding to complete was inadequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Wofford, University of Mississippi Medical Center
- Investigators
- Marion Wofford, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825188
- Sponsor's protocol ID
- 2008-0035
- Status last verified
- Mar 2014
- First submitted
- 16 Jan 2009
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00825188
- Acronym / sponsor ID
- 2008-0035
- Conditions
- Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding to complete was inadequate
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eplerenone | Active comparator | Drug: eplerenone, amlodipine, Drug: eplerenone, Drug: amlodipine |
| amlodipine | Active comparator | Drug: eplerenone, amlodipine, Drug: eplerenone, Drug: amlodipineAmlodipine 5-10mg daily times 8 weeks |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eplerenone, amlodipineAlso: Inspra, NorvascEplerenone 25mm qd versus amlodipine 5mg qd x 4weeks the Eplerenone 50mg qd versus amlodipine 10mg qd x 4weeks | Drug | amlodipine, eplerenone |
| eplerenoneAlso: InspraEplerenone 25-50mg daily x 8 weeks | Drug | eplerenone |
| eplerenoneAlso: Inspra, Norvasceplerenone 25- 50 mg daily for 8 weeks | Drug | amlodipine, eplerenone |
| amlodipineAlso: Norvascamlodipine 5-10mg daily for 8 weeks | Drug | amlodipine, eplerenone |
Primary outcome
Basal metabolic rate
Time frame: Pre and post treatment
Results and safety
The study was stopped early (reason given: funding to complete was inadequate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Wofford, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eplerenone, amlodipine, eplerenone and amlodipine in people with Obesity and Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding to complete was inadequate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal metabolic rate (time frame: Pre and post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.