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Sponsored by: |
Amylin Pharmaceuticals, Inc. |
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Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00444561 |
This exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.
Condition | Intervention | Phase |
---|---|---|
Overweight Obesity |
Drug: pramlintide acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Phase 2, Randomized, Double‑Blind, Placebo‑Controlled, Multicenter Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects |
Estimated Enrollment: | 184 |
Study Start Date: | August 2004 |
Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded:
United States, California | |
Research Site | |
Long Beach, California, United States | |
Research Site | |
Chula Vista, California, United States | |
Research Site | |
San Diego, California, United States | |
United States, Florida | |
Research Site | |
Fort Lauderdale, Florida, United States | |
Research Site | |
DeLand, Florida, United States | |
United States, Kentucky | |
Research Site | |
Lexington, Kentucky, United States | |
United States, Louisiana | |
Research Site | |
New Orleans, Louisiana, United States | |
Research Site | |
Baton Rouge, Louisiana, United States | |
United States, Montana | |
Research Site | |
Butte, Montana, United States | |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States |
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, Inc. |
Study ID Numbers: | 137-160 |
Study First Received: | March 6, 2007 |
Last Updated: | March 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00444561 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pramlintide Symlin Amylin |
Body Weight Signs and Symptoms Obesity Hypoglycemic Agents Amylin |
Nutrition Disorders Pramlintide Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity Hypoglycemic Agents Physiological Effects of Drugs |
Nutrition Disorders Pramlintide Overnutrition Overweight Pharmacologic Actions |