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

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.

Sponsored by:	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

Drug Information available for:

Octreotide Octreotide acetate

U.S. FDA Resources

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

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

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

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

Study placed in the following topic categories:

Bone Diseases, Endocrine

Hypothalamic Diseases

Pituitary Diseases

Musculoskeletal Diseases

Octreotide

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Bone Diseases

Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Nervous System Diseases

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008