A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00189514 |
|
Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : June 11, 2015
|
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
| 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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. [ Time Frame: open ended ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has completed Protocol 137OB-201.
Information from the National Library of Medicine
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
Locations
| United States, California | |
| Research Site | |
| Chula Vista, California, United States | |
| Research Site | |
| San Diego, California, United States | |
| Research Site | |
| Walnut Creek, California, United States | |
| United States, Florida | |
| Research Site | |
| Miami, Florida, United States | |
| United States, Georgia | |
| Research Site | |
| Augusta, Georgia, United States | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| Research Site | |
| Overland Park, Kansas, United States | |
| United States, Louisiana | |
| Research Site | |
| Baton Rouge, Louisiana, United States | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| Research Site | |
| Edina, Minnesota, United States | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, Ohio | |
| Research Site | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States | |
| United States, Washington | |
| Research Site | |
| Olympia, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by AstraZeneca:
|
obesity weight loss Amylin pramlintide |
Additional relevant MeSH terms:
|
Body Weight Pramlintide Hypoglycemic Agents Physiological Effects of Drugs |