Study identifier:AFA203
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
overweight
Phase 2
No
pramlintide acetate, sibutramine, phentermine, placebo
All
258
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
N/A
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.
Location
Location
New York, NY, United States
Location
Louisville, KY, United States
Location
Chula Vista, CA, United States
Location
Miami, FL, United States
Location
Pembroke Pines, FL, United States
Location
Raleigh, NC, United States
Location
Phoenix, AZ, United States
Location
Austin, TX, United States
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 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.