An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Patients With Acromegaly

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171730

Purpose

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. This study will assess the long-term safety and efficacy of pasireotide in patients with acromegaly.

Condition	Intervention	Phase
Acromegaly	Drug: Pasireotide	Phase II

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Pasireotide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Patients With Acromegaly

Further study details as provided by Novartis:

Primary Outcome Measures:

Circulating GH- and IGF-1 concentrations measured every 4 weeks

Secondary Outcome Measures:

Long-term safety and efficacy of multiple doses of Pasireotide s.c.

Estimated Enrollment:	30
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients who have completed all four treatment regimens in the core study CSOM230B2201 and achieved biochemical control in GH and IGF-1 levels after at least one month of pasireotide administration at any of the three doses
Patients who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201

Exclusion Criteria

Patients who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201
Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201 Patients who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171730

Locations

United States, Michigan
University of MI Medical Center
Ann Arbor, Michigan, United States, 48104
United States, New York
NYU/VA Medical Center
New York, New York, United States, 10010
Belgium
Novartis Investigative Site
Edegem, Belgium
France
Novartis Investigative site
Toulouse, France

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSOM230B2201E1
Study First Received:	September 13, 2005
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00171730
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Acromegaly
Pasireotide
GH
IGF-1

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Musculoskeletal Diseases
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009