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.

First Received: September 4, 2003 Last Updated: April 3, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00068042

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Octreotide acetate Octreotide

U.S. FDA Resources

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

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:

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

No publications provided

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

Additional relevant MeSH terms:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Endocrine System Diseases

Octreotide
Brain Diseases
Bone Diseases
Pharmacologic Actions
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly

ClinicalTrials.gov processed this record on November 09, 2009