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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Atenolol; Losartan; Olmesartan; Olmesartan Medoxomil

Criteria

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