NCT01137682

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Pasireotide	* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or * Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
DRUG	octreotide LAR 30mg	In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
DRUG	lanreotide ATG 120mg	In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization

Timeline

• Start date: 2010-07-19
• Primary completion: 2013-01-22
• Completion: 2017-02-28
• First posted: 2010-06-04
• Last updated: 2018-04-05
• Results posted: 2015-01-21

Locations

60 sites across 18 countries: United States, Argentina, Belgium, Brazil, Canada, Colombia, France, Germany, Israel, Italy, Norway, Poland, Romania, Russia, Saudi Arabia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study