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

Completed · Phase 4

Conditions studied: Hypertension, Insulin Resistance, Metabolic Syndrome

In brief

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

Key facts

Study ID

NCT00185094

Run by

Daiichi Sankyo

People needed

60

Starts

2004-02-01

Expected to finish

2005-07-01

Last updated by the study team

2005-12-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Diego, California, United States
• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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