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Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease — LINC-4  

Cushing's Disease Clinical Trial

Official title:
A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease

Clinical Trial Summary

The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

Clinical Trial Description

The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease. Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1 ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history of pituitary radiation. After Week 12, all patients received open-label osilodrostat until the end of the Core phase at Week 48 (Period 2). After Week 48, patients could join an optional 48 week extension period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02697734
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date October 3, 2016
Completion date December 31, 2020
View Details
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