A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
NCT ID: NCT00189514
Last Updated: 2015-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
2005-09-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
2
pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
3
pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
4
placebo
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
Interventions
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pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
placebo
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Chula Vista, California, United States
Research Site
San Diego, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Miami, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Olympia, Washington, United States
Countries
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References
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Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.
Other Identifiers
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137OB-201E
Identifier Type: -
Identifier Source: org_study_id
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