NCT01374906

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Conditions

• Cushing's Disease

Interventions

Type	Name	Description
DRUG	pasireotide LAR	Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).
DRUG	SOM230 LAR 30 mg	starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.
DRUG	SOM230 LAR 10 mg	starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Timeline

• Start date: 2011-11-04
• Primary completion: 2016-12-21
• Completion: 2016-12-21
• First posted: 2011-06-16
• Last updated: 2018-05-22
• Results posted: 2018-04-11

Locations

82 sites across 20 countries: United States, Argentina, Belgium, Brazil, Canada, China, France, Germany, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Spain, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study