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

Descriptive Information
Brief Title ^†	An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly
Official Title ^†	An Extension Study to Assess the Long-term Safety and Efficacy of Pasireotide in Patients With Acromegaly
Brief Summary	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.
Detailed Description
Study Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure ^†	Circulating GH- and IGF-1 concentrations measured every 4 weeks
Secondary Outcome Measure ^†	Long-term safety and efficacy of multiple doses of Pasireotide s.c.
Condition ^†	Acromegaly
Intervention ^†	DrugPasireotide
Study Arms / Comparison Groups	Pasireotide s.c. (SOM230)
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	30
Start Date ^†	August 2004
Completion Date
Primary Completion Date	December 2011
Eligibility 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.
Gender	Both
Ages	18 Years - 80 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	Belgium, France, United States,
Administrative Information
NCT ID ^†	NCT00171730
Organization ID	CSOM230B2201E1
Secondary IDs ^††
Responsible Party	,
Study Sponsor ^†	Novartis Pharmaceuticals
Collaborators ^††
Investigators ^†	Study Chair: Novartis, Novartis
Information Provided By	Novartis
Verification Date	December 2011
First Received Date ^†	September 13, 2005
Last Updated Date	December 8, 2011

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.