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
Study identifier:AFA203
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
overweight
Phase
Phase 2
Healthy volunteers
No
Study drug
pramlintide acetate, sibutramine, phentermine, placebo
Sex
All
Actual Enrollment
258
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Nov 2006
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Aug 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
N/A
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 | Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin |
| Experimental: 2 | Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin Drug: sibutramine oral tablet, once a day, 10mg Other Name: Meridia |
| Experimental: 3 | Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Name: Symlin Drug: phentermine oral tablet, once a day, 37.5mg Other Name: Adipex-P Other Name: Fastin Other Name: Obenix Other Name: Oby-Trim |
| Placebo Comparator: 4 | Drug: placebo subcutaneous injection, three times a day |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
