NCT00143416

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

First QC Date

September 1, 2005

Last Update Submit

July 24, 2008

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • PK/PD evaluation

Interventions

PegvisomantDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Switching to other therapeutic methods for acromegaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Kobe, Hyogo PREF, 650-0017, Japan

Location

Pfizer Investigational Site

Kozukue-cho, Kouhoku-ku, Yokohama-shi, Kanagawa, 222-0036, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, 612-8555, Japan

Location

Pfizer Investigational Site

Hamamatsu, Shizuoka, 431-3124, Japan

Location

Pfizer Investigational Site

Bonkyo-ku, Tokyo, 113-0022, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Pfizer Investigational Site

Gakuhara, Kishiwada, Osaka, 596-8501, Japan

Location

Pfizer Investigational Site

Sannomaru-cho, Naka-ku, Nagoya-shi, 460-0001, Japan

Location

Related Links

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

April 1, 2004

Study Completion

July 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

JP(8)