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A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00068042
First received: September 4, 2003
Last updated: April 3, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: Pegvisomant
Drug: Sandostatin LAR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 100
Study Start Date: April 2003
Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068042

  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00068042     History of Changes
Other Study ID Numbers: PEGA-0435-003, A6291004
Study First Received: September 4, 2003
Last Updated: April 3, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014