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A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

This study has been completed.
Sponsor:
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00189514
First received: September 12, 2005
Last updated: December 19, 2007
Last verified: December 2007
History of Changes

September 12, 2005
December 19, 2007
September 2005
June 2007   (final data collection date for primary outcome measure)
  • Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. [ Time Frame: open ended ] [ Designated as safety issue: No ]
  • Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. [ Time Frame: open ended ] [ Designated as safety issue: No ]
  • *Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
  • *Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.
Complete list of historical versions of study NCT00189514 on ClinicalTrials.gov Archive Site
Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. [ Time Frame: open ended ] [ Designated as safety issue: No ]
*Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.
Not Provided
Not Provided
 
A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: pramlintide acetate
    Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
    Other Name: Symlin
  • Drug: placebo
    subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
  • Experimental: 1
    Intervention: Drug: pramlintide acetate
  • Experimental: 2
    Intervention: Drug: pramlintide acetate
  • Experimental: 3
    Intervention: Drug: pramlintide acetate
  • Placebo Comparator: 4
    Intervention: Drug: placebo
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. Epub 2008 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has completed Protocol 137OB-201.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00189514
137OB-201E
No
Lisa Porter, MD, Study Director, Amylin Pharmaceuticals
Amylin Pharmaceuticals, LLC.
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP