Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00185094
Enrollment
60
Registered
2005-09-16
Start date
2004-02-29
Completion date
2005-07-31
Last updated
2005-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Insulin Resistance, Metabolic Syndrome

Brief summary

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

Interventions

DRUGOlmesartan medoxomil
DRUGLosartan potassium
DRUGAtenolol

Sponsors

Daiichi Sankyo
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity

Secondary

MeasureTime frame
-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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026