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

Daiichi Sankyo

Status and phase

Completed

Phase 4

Conditions

Hypertension

Insulin Resistance

Metabolic Syndrome

Treatments

Drug: Atenolol

Drug: Losartan potassium

Drug: Olmesartan medoxomil

Study type

Interventional

Funder types

Industry

Identifiers

866-440

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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