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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00146289 |
Purpose
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Insulin Resistance |
Drug: MICARDIS® (telmisartan) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | A Randomised, DB, Placebo-Controlled, Parallel Group, 16-wk MICARDIS (160mg) Tab, Proof-of-Concept, Evaluating Insulin Sensitivity in Overweight or Obese, Non-Diabetic, Normotensive, Using the OGTT, With a Clamp Sub-Group |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
Contacts and Locations| United States, California | |
| UCLA School of Medicine- Divison of Endocrinology | |
| Los Angeles, California, United States | |
| University of CA at SanDiego- Department of Endocrinology | |
| San Diego, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Westlake Village, California, United States | |
| United States, Illinois | |
| Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States | |
| United States, Ohio | |
| Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| United States, Tennessee | |
| Boehringer Ingelheim Investigational Site | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Boehringer Ingelheim Investigational Site | |
| Harker Heights, Texas, United States | |
| Canada, Manitoba | |
| University of Manitoba, Diabetes Research Group | |
| Winnipeg, Manitoba, Canada | |
| Canada, Ontario | |
| St. Joseph's Health Care London | |
| London, Ontario, Canada | |
| The Ottawa Hospital - Riverside Campus | |
| Ottawa, Ontario, Canada | |
| Denmark | |
| Århus Sygehus | |
| Aarhus C, Denmark | |
| Germany | |
| Boehringer Ingelheim Investigational Site | |
| Unterschneidheim, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Künzing, Germany | |
| Universitätsmedizin Berlin | |
| Berlin, Germany | |
| Italy | |
| Policlinico Monteluce | |
| PERUGIA, Italy | |
| Azienda Ospedale Università di Pisa | |
| PISA, Italy | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 502.469 |
| Study First Received: | September 2, 2005 |
| Last Updated: | November 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00146289 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity Metabolic Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Overweight Pharmacologic Actions Protease Inhibitors Body Weight Angiotensin II Type 1 Receptor Blockers |
Hyperinsulinism Signs and Symptoms Angiotensin-Converting Enzyme Inhibitors Nutrition Disorders Overnutrition Insulin Resistance Telmisartan Glucose Metabolism Disorders |