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 - Tabular View

Tracking Information
First Received Date ^ICMJE	September 9, 2005
Last Updated Date	December 22, 2005
Start Date ^ICMJE	February 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 9, 2005)	To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00185094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 9, 2005)	-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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension
Brief Summary	To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hypertension Insulin Resistance Metabolic Syndrome
Intervention ^ICMJE	Drug: Olmesartan medoxomil Drug: Losartan potassium Drug: Atenolol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	July 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00185094
Responsible Party
Study ID Numbers ^ICMJE	866-440
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Daiichi Sankyo Inc.
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP