A Study to Examine the Long Term Effect of Pramlintide on Body Weight and its Safety and Tolerability in Obese Subjects
Study identifier:137OB-201E
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
obesity
Phase
Phase 2
Healthy volunteers
No
Study drug
pramlintide acetate, placebo
Sex
All
Actual Enrollment
210
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Sept 2005
Primary Completion Date: 01 Jun 2007
Study Completion Date: 01 Jun 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double 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, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin |
| Experimental: 2 | Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin |
| Experimental: 3 | Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin |
| Placebo Comparator: 4 | Drug: placebo subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
