Status:
COMPLETED
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
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Insulin Resistance
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00185094
Start Date
February 1 2004
End Date
July 1 2005
Last Update
December 23 2005
Active Locations (10)
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Birmingham, Alabama, United States
2
San Diego, California, United States
3
Miami, Florida, United States
4
Indianapolis, Indiana, United States