A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
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ClinicalTrials.gov Identifier: NCT00189514 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : June 11, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: pramlintide acetate Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | June 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Name: Symlin |
Experimental: 2 |
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Name: Symlin |
Experimental: 3 |
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Name: Symlin |
Placebo Comparator: 4 |
Drug: placebo
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate |
- Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. [ Time Frame: open ended ]
- Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. [ Time Frame: open ended ]
- Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. [ Time Frame: open ended ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has completed Protocol 137OB-201.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189514
United States, California | |
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Chula Vista, California, United States | |
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San Diego, California, United States | |
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Walnut Creek, California, United States | |
United States, Florida | |
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Miami, Florida, United States | |
United States, Georgia | |
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Augusta, Georgia, United States | |
United States, Illinois | |
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Chicago, Illinois, United States | |
United States, Indiana | |
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Indianapolis, Indiana, United States | |
United States, Kansas | |
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Overland Park, Kansas, United States | |
United States, Louisiana | |
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Baton Rouge, Louisiana, United States | |
United States, Michigan | |
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Detroit, Michigan, United States | |
United States, Minnesota | |
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Edina, Minnesota, United States | |
United States, Missouri | |
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St. Louis, Missouri, United States | |
United States, Montana | |
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Butte, Montana, United States | |
United States, New York | |
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New York, New York, United States | |
United States, Ohio | |
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Cincinnati, Ohio, United States | |
United States, Oregon | |
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Portland, Oregon, United States | |
United States, Pennsylvania | |
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Philadelphia, Pennsylvania, United States | |
United States, Texas | |
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Austin, Texas, United States | |
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San Antonio, Texas, United States | |
United States, Utah | |
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Salt Lake City, Utah, United States | |
United States, Washington | |
Research Site | |
Olympia, Washington, United States |
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00189514 |
Other Study ID Numbers: |
137OB-201E |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | June 11, 2015 |
Last Verified: | May 2015 |
obesity weight loss Amylin pramlintide |
Body Weight Pramlintide Hypoglycemic Agents Physiological Effects of Drugs |