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| Sponsor: | Brigham and Women's Hospital |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00675987 |
Purpose
The main purposes of this study are to find out if the study drug losartan (Cozaar) or placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to insulin) and to measure the effect of the study drug losartan or placebo on how the arteries in your arm dilate (enlarge to carry more blood).
We hope to learn if taking losartan changes the amount of certain proteins in the blood that effect blood vessel function.
Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4 months for you to complete this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Hypertension Hyperglycemia |
Drug: losartan Drug: Placebo control |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Protocol Merck 318-00: A Double-Blind, Placebo-Controlled, Randomized, Parallel, Clinical Trial To Study The Effect Of Losartan Potassium On Endothelial Dysfunction And Insulin Resistance In Obese Patients With Impaired Fasting Glucose |
| Enrollment: | 153 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Losartan 100 mg 1 tab po QD
|
Drug: losartan
losartan 100 mg tablets 1 tab po QD
Other Name: Cozaar
|
|
Placebo Comparator: 2
Placebo 1 tab po QD
|
Drug: Placebo control
Placebo 1 po QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| CAVS Clinical Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| VA San Diego Health Care System | |
| San Diego, California, United States, 92161 | |
| United States, Florida | |
| University of Miami Diabetes Research Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital Cardiovascular Division | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| St. Lukes Roosevelt Hospital | |
| New York, New York, United States, 10025 | |
| United States, Pennsylvania | |
| University of Pennsylvania School of Medicine | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas SW Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| Hypertension Clinical Pharmacology Baylor Clinic | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Mark A Creager, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Mark A. Creager, MD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00675987 History of Changes |
| Other Study ID Numbers: | 2007-P-000490 |
| Study First Received: | May 8, 2008 |
| Last Updated: | February 2, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Impaired Fasting Glucose FPG >100-<126 mg/dL |
|
Hyperglycemia Hypertension Insulin Resistance Obesity Glucose Metabolism Disorders Metabolic Diseases Vascular Diseases Cardiovascular Diseases Hyperinsulinism Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Losartan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |