Long Term Study With B2036-PEG - Full Text View

Purpose

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

Condition	Intervention	Phase
Acromegaly	Drug: Pegvisomant	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143416

Locations


Japan
	Pfizer Investigational Site
	gakuhara, kishiwada, osaka, Japan, 596-8501
	Pfizer Investigational Site
	sannomaru-cho, naka-ku, nagoya-shi, Japan, 460-0001
	Pfizer Investigational Site
	Kyoto, Japan, 612-8555

Japan, HYOGO PREF
	Pfizer Investigational Site
	KOBE CITY, HYOGO PREF, Japan, 650-0017

Japan, Kanagawa
	Pfizer Investigational Site
	kozukue-cho, kouhoku-ku, yokohama-shi, Kanagawa, Japan, 222-0036

Japan, Shizuoka-Ken
	Pfizer Investigational Site
	HAMAMATSU-SHI, Shizuoka-Ken, Japan, 431-3124

Japan, TOKYO
	Pfizer Investigational Site
	BONKYO-KU, TOKYO, Japan, 113-0022

Japan, Tokyo
	Pfizer Investigational Site
	Shinjuku-ku, Tokyo, Japan, 162-8666

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Study ID Numbers:	A6291011
First Received:	September 1, 2005
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00143416
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Bone Diseases, Endocrine

Hypothalamic Diseases

Pituitary Diseases

Musculoskeletal Diseases

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Bone Diseases

Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143416