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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

Primary Purpose

Hypertension, Insulin Resistance, Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Olmesartan medoxomil
Losartan potassium
Atenolol
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
December 22, 2005
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00185094
Brief Title
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
Official Title
The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Insulin Resistance, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Type
Drug
Intervention Name(s)
Losartan potassium
Intervention Type
Drug
Intervention Name(s)
Atenolol
Primary Outcome Measure Information:
Title
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary Outcome Measure Information:
Title
-To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
Title
-To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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