Status:
COMPLETED
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety an...
Eligibility Criteria
Inclusion
- Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses.
- Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.
Exclusion
- Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201.
- Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201.
- Participants 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.
Key Trial Info
Start Date :
August 24 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00171730
Start Date
August 24 2004
End Date
December 6 2013
Last Update
September 5 2021
Active Locations (10)
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1
Cedars Sinai Medical Center Dept. of Pituitary Ctr.
Los Angeles, California, United States, 90048
2
University of Michigan Health System StudyCoordinatorCSOM230B2201E1
Ann Arbor, Michigan, United States, 48109
3
NYU / VA Medical Center
New York, New York, United States, 10010
4
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102