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A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
This study has been completed.
Study NCT00402077   Information provided by Amylin Pharmaceuticals, Inc.
First Received: November 17, 2006   Last Updated: January 8, 2008   History of Changes

November 17, 2006
January 8, 2008
November 2006
August 2007   (final data collection date for primary outcome measure)
  • All treatment-emergent adverse events occurring during the 24-week treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute change in body weight from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • All treatment-emergent adverse events occurring during the 24-week treatment period
  • Absolute change in body weight from baseline to Week 12
Complete list of historical versions of study NCT00402077 on ClinicalTrials.gov Archive Site
  • Percent change in body weight from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent change in body weight from baseline to Week 12
  • Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
  • Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
  • Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
  • Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
  • Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
  • Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
 
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.

 
Phase II
Interventional
Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Overweight
  • Obesity
  • Drug: pramlintide acetate
  • Drug: sibutramine
  • Drug: phentermine
  • Drug: placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
258
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
  • Has been obese or overweight for at least one year prior to study start
  • Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin

Exclusion Criteria:

  • Is currently enrolled in or is planning to enroll in a formal weight-loss program
  • Is unwilling or unable to participate in a lifestyle intervention program as part of the study
  • Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
  • Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
  • Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
  • Has previously used pramlintide either by prescription or as part of a clinical study
  • Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
  • Has donated blood within 2 months before study start, or is planning to donate blood during the study
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402077
Lisa Porter, MD, Study Director, Amylin Pharmaceuticals
AFA203
Amylin Pharmaceuticals, Inc.
 
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, Inc.
Amylin Pharmaceuticals, Inc.
January 2008

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