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NCT00189514 Clinical Trial

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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189514
Other study ID # 137OB-201E
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated June 10, 2015
Start date September 2005
Est. completion date June 2007

Study information
Verified date May 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Subject has completed Protocol 137OB-201.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
• placebo
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Locations
Country Name City State
United States Research Site Augusta Georgia
United States Research Site Austin Texas
United States Research Site Baton Rouge Louisiana
United States Research Site Butte Montana
United States Research Site Chicago Illinois
United States Research Site Chula Vista California
United States Research Site Cincinnati Ohio
United States Research Site Detroit Michigan
United States Research Site Edina Minnesota
United States Research Site Indianapolis Indiana
United States Research Site Miami Florida
United States Research Site New York New York
United States Research Site Olympia Washington
United States Research Site Overland Park Kansas
United States Research Site Philadelphia Pennsylvania
United States Research Site Portland Oregon
United States Research Site Salt Lake City Utah
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site St. Louis Missouri
United States Research Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. open ended No
Primary Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. open ended No
Secondary Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. open ended No
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