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

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00189514

Purpose

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	Intervention	Phase
Obesity	Drug: pramlintide acetate Drug: placebo	Phase II

MedlinePlus related topics: Obesity

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ]

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 ] [ Designated as safety issue: No ]

Enrollment:	210
Study Start Date:	September 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
2: Experimental	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
3: Experimental	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
4: Placebo Comparator	Drug: placebo subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Subject has completed Protocol 137OB-201.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189514

Show 21 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	137OB-201E
Study First Received:	September 12, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00189514 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

obesity
weight loss
Amylin
pramlintide

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Hypoglycemic Agents
Amylin

Weight Loss
Nutrition Disorders
Pramlintide
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Hypoglycemic Agents
Physiological Effects of Drugs

Nutrition Disorders
Pramlintide
Overweight
Overnutrition
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009