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A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00189514
First received: September 12, 2005
Last updated: June 10, 2015
Last verified: May 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Drug: pramlintide acetate Drug: placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. [ Time Frame: open ended ]
- Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. [ Time Frame: open ended ]
Secondary Outcome Measures:
- Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. [ Time Frame: open ended ]
| Enrollment: | 210 |
| Study Start Date: | September 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has completed Protocol 137OB-201.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189514
Show 21 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189514
Show 21 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00189514 History of Changes |
| Other Study ID Numbers: |
137OB-201E |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 10, 2015 |
Keywords provided by AstraZeneca:
|
obesity weight loss Amylin pramlintide |
Additional relevant MeSH terms:
|
Body Weight Signs and Symptoms Pramlintide Islet Amyloid Polypeptide Hypoglycemic Agents |
Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 19, 2017