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
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Insulin Resistance; Metabolic Syndrome
Intervention: Olmesartan medoxomil (Drug); Losartan potassium (Drug); Atenolol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
Summary
To examine the effect of three different blood pressure medications on the insulin
sensitivity in overweight patients with high blood pressure.
Clinical Details
Official title: The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary outcome: -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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Birmingham, Alabama, United States
San Diego, California, United States
Miami, Florida, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Dallas, Texas, United States
Additional Information
Starting date: February 2004
Ending date: July 2005
Last updated: December 22, 2005
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