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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185094
• Other study ID #: 866-440
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: December 22, 2005
• Start date: February 2004
• Est. completion date: July 2005

Study information

• Verified date: September 2005
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Olmesartan medoxomil

• Losartan potassium

• Atenolol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity
Secondary	-To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity
Secondary	-To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity