Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Amylin Pharmaceuticals, LLC..
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT00819234

First received: December 24, 2008

Last updated: January 7, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 24, 2008

Last Updated Date

January 7, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Examine the long-term safety, tolerability, and effect on body weight of pramlintide administered in combination with various doses of metreleptin in obese and overweight subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00819234 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To investigate the long-term effect on waist circumference, fasting circulating metabolic parameters, patient-reported outcomes. To examine metreleptin pharmacokinetics and anti-metreleptin antibody titer [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

Official Title ^ICMJE

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin in Obese and Overweight Subjects

Brief Summary

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: Placebo
placebo pramlintide and placebo metreleptin twice daily
Drug: Pramlintide and Metreleptin
Subcutaneous injection, twice daily

Other Name: Symlin

Study Arm (s)

Placebo Comparator: 1
Intervention: Drug: Placebo
Experimental: 2
Pramlintide and 1.25mg Metreleptin

Intervention: Drug: Pramlintide and Metreleptin
Experimental: 3
Pramlintide and 2.5mg Metreleptin

Intervention: Drug: Pramlintide and Metreleptin
Experimental: 4
Pramlintide and 5.0mg Metreleptin

Intervention: Drug: Pramlintide and Metreleptin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
Male, or female and meets all the following criteria:
1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria:

Is expected to require or undergo treatment with any exclusionary medication.
Is undesirable as a study participant as judged by the investigator

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00819234

Other Study ID Numbers ^ICMJE

DFA102E

Has Data Monitoring Committee

Responsible Party

Lisa Porter, MD, V.P. Clinical Development, Amylin Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, LLC.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jean Chan, MD

Amylin Pharmaceuticals, LLC.

Information Provided By

Amylin Pharmaceuticals, LLC.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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