NCT00600886

Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment. The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months. Following one year of treatment patients could proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Pasireotide	Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days.
DRUG	Octreotide	Octreotide LAR - i.m. depot injection given once every 28 days.

Timeline

• Start date: 2008-02-11
• Primary completion: 2016-03-11
• Completion: 2016-03-11
• First posted: 2008-01-25
• Last updated: 2017-07-02
• Results posted: 2015-01-30

Locations

95 sites across 27 countries: United States, Argentina, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom