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

• Status: Completed
• Trial end date: 2013-12-06
• Target enrollment: 0
• Participant gender: All

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 and efficacy of pasireotide in participants with acromegaly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pasireotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.