Skip to main content
OpenTrials
Completed

NCT Number: NCT00185094

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

Losartan Potassium

Drug

Atenolol

Drug

Primary outcomes

  1. To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity

Secondary outcomes

  1. -To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity

  2. -To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Dec 23, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.