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

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00185094

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Insulin Resistance Metabolic Syndrome	Drug: Olmesartan medoxomil Drug: Losartan potassium Drug: Atenolol	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension

Study Start Date :

Feb 1, 2004

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity []

Secondary Outcome Measures

-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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	San Diego	California	United States
3	Miami	Florida	United States
4	Indianapolis	Indiana	United States
5	Baltimore	Maryland	United States
6	Boston	Massachusetts	United States
7	Rochester	Minnesota	United States
8	Philadelphia	Pennsylvania	United States
9	Dallas	Texas	United States
10	San Antonio	Texas	United States