A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pegvisomant
Sandostatin LAR
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
Inclusion Criteria: Diagnosis of acromegaly IGF-I levels >=1.3xULN (upper limit of normal) at screening No history of radiotherapy or prior treatment with other drugs for acromegaly Minimum of two months must have elapsed post surgery prior to screening Exclusion Criteria: Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations AST/ALT >= 3xULN (upper limit of normal) Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI Visual field defects (except post surgical stable residual defects) Unable to self administer drug
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Secondary Outcome Measures
The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00068042
Brief Title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Official Title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR
Primary Outcome Measure Information:
Title
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Secondary Outcome Measure Information:
Title
The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acromegaly
IGF-I levels >=1.3xULN (upper limit of normal) at screening
No history of radiotherapy or prior treatment with other drugs for acromegaly
Minimum of two months must have elapsed post surgery prior to screening
Exclusion Criteria:
Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
AST/ALT >= 3xULN (upper limit of normal)
Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
Visual field defects (except post surgical stable residual defects)
Unable to self administer drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0030
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0108
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Pfizer Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-060
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 2W5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Pfizer Investigational Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
State/Province
Attika/Greece
ZIP/Postal Code
10676
Country
Greece
Facility Name
Pfizer Investigational Site
City
Piraeus
ZIP/Postal Code
18537
Country
Greece
Facility Name
Pfizer Investigational Site
City
Cork
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin 9
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
Country
Italy
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Pfizer Investigational Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Pfizer Investigational Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Belfast
State/Province
Ireland
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=PEGA-0435-003&StudyName=A+Study+To+Compare+The+Efficacy+And+Safety+Of+Pegvisomant+To+That+Of+Sandostatin+Lar+Depot+In+Patients+With+Acromegaly
Description
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Learn more about this trial
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
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