NCT02310269

Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

Conditions

• Cushings Disease

Interventions

Type	Name	Description
DRUG	Pasireotide

Timeline

• Start date: 2013-03-28
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2014-12-08
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

54 sites across 11 countries: United States, Canada, Colombia, France, Germany, Israel, Italy, Lebanon, Netherlands, Romania, United Kingdom