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:
Daiichi Sankyo Inc.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185094
First received: September 9, 2005
Last updated: December 22, 2005
Last verified: September 2005
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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:
Drug Information available for:
Potassium bicarbonate
Potassium chloride
Atenolol
Losartan
Losartan potassium
Olmesartan
Olmesartan medoxomil
U.S. FDA Resources
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
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 June 17, 2013