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Home > "A" Clinical Trials Conditions > A Study to Compare the Efficacy and Safety of Pegvisomant to that of Sandostatin LAR in Patients with Acromegaly

A Study to Compare the Efficacy and Safety of Pegvisomant to that of Sandostatin LAR in Patients with Acromegaly



A Study to Compare the Efficacy and Safety of Pegvisomant to that of Sandostatin LAR in Patients with Acromegaly

For Condition: Acromegaly
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: The pupose 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. 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
Total Enrollment: 

Location and Contact Information:

Research Center *Recruiting*
Halifax,  Nova Scotia,  B3H 2YR
Canada
Recruiting  

Research Center *Recruiting*
Manchester,  ,  M20 4BX
United Kingdom
Recruiting  

Research Center *Recruiting*
Stockholm,  ,  171 76
Sweden
Recruiting  

Research Center *Recruiting*
ESSEN,  , 
Germany
Recruiting  

Research Center *Recruiting*
London,  ,  EC1A 78E
United Kingdom
Recruiting  

Research Center *Recruiting*
London,  ,  SE1 7EH
United Kingdom
Recruiting  

Research Center *Recruiting*
Fitzroy,  Victoria,  3065
Australia
Recruiting  

Research Center *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting  

Research Center *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting  

Research Center *Recruiting*
Cork,  , 
Ireland
Recruiting  

Research Center *Recruiting*
Sevilla,  ,  41013
Spain
Recruiting  

Research Center *Recruiting*
Leeds,  ,  LS1 3EX
United Kingdom
Recruiting  

Research Center *Recruiting*
Berlin,  ,  10117
Germany
Recruiting  

Research Center *Recruiting*
Montreal,  Quebec,  H2L 2W5
Canada
Recruiting  

Research Center *Recruiting*
Chapel Hill,  North Carolina,  27599
United States
Recruiting  

Research Center *Recruiting*
Genova,  ,  16132
Italy
Recruiting  

Research Center *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting  

Research Center *Recruiting*
Chicago,  Illinois, 
United States
Recruiting  

Research Center *Recruiting*
Dublin,  , 
Ireland
Recruiting  

Research Center *Recruiting*
Dresden,  ,  01307
Germany
Recruiting  

Research Center *Recruiting*
Linkoping,  ,  581 85
Sweden
Recruiting  

Research Center *Recruiting*
Torino,  , 
Italy
Recruiting  

Research Center *Recruiting*
Le Kremlin-Bicetre,  ,  94275
France
Recruiting  

Research Center *Recruiting*
Barcelona,  ,  08916
Spain
Recruiting  

Research Center *Recruiting*
Heidelberg,  ,  69120
Germany
Recruiting  

Research Center *Recruiting*
Toronto,  Ontario,  M5G 1X5
Canada
Recruiting  

Research Center *Recruiting*
Roma,  ,  00168
Italy
Recruiting  

Research Center *Recruiting*
Ann Arbor,  Michigan,  48109
United States
Recruiting  

Research Center *Recruiting*
Oslo,  ,  0027
Norway
Recruiting  

Research Center *Recruiting*
Pessac,  ,  33604
France
Recruiting  

Research Center *Recruiting*
Pittsburgh,  Pennsylvania,  15212
United States
Recruiting  

Research Center *Recruiting*
Barcelona,  ,  08907
Spain
Recruiting  

Research Center *Recruiting*
Chicago,  Illinois, 
United States
Recruiting  

Research Center *Recruiting*
Cork,  , 
Ireland
Recruiting  

Research Center *Recruiting*
Belfast,  Ireland,  BT12 6BA
United Kingdom
Recruiting  

Research Center *Recruiting*
Belfast,  ,  BT12 6BA
Ireland
Recruiting  

Research Center *Recruiting*
Madrid,  ,  28035
Spain
Recruiting  


Additional Information:
Study ID Numbers:
  PEGA-0435-003; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068042

Other Acromegaly Studies:
1. Measurement of Outcome of Surgical Treatment in Patients With Acromegaly

2. The Treatment and Natural History of Acromegaly

3. A Study to Compare the Efficacy and Safety of Pegvisomant to that of Sandostatin LAR in Patients with Acromegaly

4. Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly

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A Study to Compare the Efficacy and Safety of Pegvisomant to that of Sandostatin LAR in Patients with Acromegaly

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