|
|
|
|
|
|
Sponsors and Collaborators: |
Brigham and Women's Hospital Merck |
Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00675987 |
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 Impaired Fasting Glucose |
Drug: losartan Drug: Placebo control |
Phase IV |
MedlinePlus related topics: | High Blood Pressure Obesity |
Drug Information available for: | Insulin Dextrose Losartan Losartan potassium Potassium chloride |
Study Type: | Interventional |
Study Design: | Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Losartan 100 mg 1 tab po QD
|
Drug: losartan
losartan 100 mg tablets 1 tab po QD
|
2: Placebo Comparator
Placebo 1 tab po QD
|
Drug: Placebo control
Placebo 1 po QD
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
CAVS Clinical Research Center | Recruiting | ||||
Little Rock, Arkansas, United States, 72205 | |||||
Contact: Angie Smither 501-257-5882 smithangelaa@uams.edu | |||||
Principal Investigator: Neda Rasouli, MD | |||||
United States, California | |||||
VA San Diego Health Care System | Recruiting | ||||
San Diego, California, United States, 92161 | |||||
Contact: Adrienne Armstrong 858-552-8585 ext 2884 adriennearmstrong@sbcglobal.net | |||||
Principal Investigator: Robert Henry, MD | |||||
United States, Florida | |||||
University of Miami Diabetes Research Institute | Recruiting | ||||
Miami, Florida, United States, 33136 | |||||
Contact: Robert Agramonte 305-243-6573 ragramon@med.miami.edu | |||||
Principal Investigator: Jennifer Marks, MD | |||||
United States, Indiana | |||||
Indiana University School of Medicine | Recruiting | ||||
Indianapolis, Indiana, United States, 46202 | |||||
Contact: Robin Chisolm 317-274-7679 rlchiso@iupui.edu | |||||
Principal Investigator: Kieren Mather, MD | |||||
United States, Massachusetts | |||||
Brigham and Women's Hospital Cardiovascular Division | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Jeanne Doyle, BS, RN, BC 617-525-7055 jdoyle7@partners.org | |||||
Contact: Nicole Navarrete 617-525-7055 nnavarrete@partners.org | |||||
Principal Investigator: Mark A Creagear, MD | |||||
United States, New York | |||||
St. Lukes Roosevelt Hospital | Recruiting | ||||
New York, New York, United States, 10025 | |||||
Contact: Sylvaine Frances 212-523-4572 sfrancis@chpnet.org | |||||
Principal Investigator: Jeannine Albu, MD | |||||
United States, Pennsylvania | |||||
University of Pennsylvania School of Medicine | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
Contact: Carissa Fuller 215-746-2084 Carissa.Fuller@uphs.upenn.edu | |||||
Principal Investigator: Michael Rickels, MD | |||||
United States, Texas | |||||
University of Texas SW Medical Center at Dallas | Recruiting | ||||
Dallas, Texas, United States, 75390 | |||||
Contact: Thanalakshmi Seenivasan 214-648-9705 Thanalakshmi.Seenivasan@UTSouthwestern.edu | |||||
Principal Investigator: Scott Grundy, MD | |||||
Hypertension Clinical Pharmacology Baylor Clinic | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Charlyne Wright 713-798-2375 cwright@bcm.tmc.edu | |||||
Principal Investigator: James Pool, MD |
Brigham and Women's Hospital |
Merck |
Principal Investigator: | Mark A Creager, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Mark A. Creager, MD ) |
Study ID Numbers: | 2007-P-000490 |
First Received: | May 8, 2008 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00675987 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|
|