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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185094
First received: September 9, 2005
Last updated: December 22, 2005
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Hypertension
Insulin Resistance
Metabolic Syndrome
Drug: Olmesartan medoxomil
Drug: Losartan potassium
Drug: Atenolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Olmesartan Medoxomil, Losartan Potassium, and Atenolol on Insulin Sensitivity in Overweight and Obese Subjects With Hypertension

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

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

Estimated Enrollment: 60
Study Start Date: February 2004
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185094

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
San Diego, California, United States
United States, Florida
Miami, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00185094     History of Changes
Other Study ID Numbers: 866-440
Study First Received: September 9, 2005
Last Updated: December 22, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Overweight
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Atenolol
Losartan
Olmesartan medoxomil
Olmesartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014