NCT Number: NCT00185094
A Comparison of the Effect of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on the Ability of Overweight Patients With High Blood Pressure to Respond to Insulin
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Birmingham, Alabama, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients between the ages of 18 and 75 years (inclusive)
- Willingness to undergo insulin clamp procedure twice
- Overweight or obese (BMI=25-39 kg/m2)
- Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure < 140 mmHg and diastolic blood pressure 90-99 mmHg
- If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study
Exclusion criteria
- Systolic blood pressure > 179 mmHg
- Diastolic blood pressure > 99 mmHg or < 85 mmHg
- Diagnosis of diabetes mellitus
- History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
- Previous history of a cerebrovascular accident or a transient ischemic attack
- History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components
- Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data
- Laboratory abnormalities that could compromise subject safety
Treatment and study plan
Losartan Potassium
DrugAtenolol
DrugPrimary outcomes
-
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary outcomes
-
-To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
-
-To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity
Sponsors and collaborators
Lead sponsor
Daiichi Sankyo
Industry
Registry information
Official study title
The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Sep 16, 2005
- Registry last updated
- Dec 23, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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