Trial record 1 of 1 for: NCT00143416

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Long Term Study With B2036-PEG

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ClinicalTrials.gov Identifier: NCT00143416

Recruitment Status : Completed

First Posted : September 2, 2005

Last Update Posted : July 29, 2008

Sponsor:

Information provided by:

Pfizer

Tracking Information

First Submitted Date ^ICMJE

September 1, 2005

First Posted Date ^ICMJE

September 2, 2005

Last Update Posted Date

July 29, 2008

Study Start Date ^ICMJE

April 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

PK/PD evaluation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long Term Study With B2036-PEG

Official Title ^ICMJE

Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -

Brief Summary

Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Drug: Pegvisomant

Study Arms ^ICMJE

Not Provided

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

Completed

Enrollment ^ICMJE

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

Exclusion Criteria:

Switching to other therapeutic methods for acromegaly

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

20 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00143416

Other Study ID Numbers ^ICMJE

A6291011

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

July 2008

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

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