CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
osilodrostat +1 moredrug
Likely dose
osilodrostat 1 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/NCT02180217
NCT02180217Phase 3Completed
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Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

Novartis Pharmaceuticals·interventional·Posted Jul 2, 2014·Updated Jan 6, 2021

In Brief

A Phase 3 clinical trial evaluating osilodrostat and LCI699 matching placebo for Cushings Disease. Completed, enrolled 137 participants across 60 sites in 19 countries.

Detailed Summary

The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU. This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCushings Disease
CountriesArgentina, Austria, Bulgaria, Canada, China, Colombia, France, Germany, India, Italy, Japan, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2, 2014
Enrollment StartOct 6, 2014
Primary CompletionFeb 21, 2018
Study CompletionDec 4, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12 years ago

Interventions

osilodrostatdrug

Osilodrostat comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat was 30 mg bid.

LCI699 matching placebodrug

Osilodrostat placebo comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat placebo was 30 mg bid.