CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
pasireotide LAR +2 moredrug
Likely dose
SOM230 LAR 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01374906
NCT01374906Phase 3Completed
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A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

Novartis Pharmaceuticals·interventional·Posted Jun 16, 2011·Updated May 22, 2018

In Brief

A Phase 3 clinical trial evaluating pasireotide LAR, SOM230 LAR 30 mg, and 1 other intervention for Cushing's Disease. Completed, enrolled 150 participants across 82 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushing's Disease
CountriesArgentina, Belgium, Brazil, Canada, China, France, Germany, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 16, 2011
Enrollment StartNov 4, 2011
Primary CompletionDec 21, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.0 years ago

Interventions

pasireotide LARdrug

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).

SOM230 LAR 30 mgdrug

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.

SOM230 LAR 10 mgdrug

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.