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

Completed · Phase 2

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT00171730

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2004-08-24

Expected to finish

2013-12-06

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai Medical Center Dept. of Pituitary Ctr. — Los Angeles, California, United States
• University of Michigan Health System StudyCoordinatorCSOM230B2201E1 — Ann Arbor, Michigan, United States
• NYU / VA Medical Center — New York, New York, United States
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Toulouse Cédex 4, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Naples, Italy
• Novartis Investigative Site — Lausanne, Switzerland

Full record on ClinicalTrials.gov

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