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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.
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Dallas, Texas, United States

San Antonio, Texas, United States

Additional Information

Starting date: February 2004
Last updated: December 22, 2005

Page last updated: August 23, 2015

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