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

NCT ID: NCT00185094

Last Updated: 2005-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-07-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension Insulin Resistance Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Olmesartan medoxomil

Intervention Type DRUG

Losartan potassium

Intervention Type DRUG

Atenolol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Locations

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Birmingham, Alabama, United States

Site Status

San Diego, California, United States

Site Status

Miami, Florida, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Rochester, Minnesota, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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866-440

Identifier Type: -

Identifier Source: org_study_id