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Completed Phase 3 Interventional Results available

Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

ClinicalTrials.gov ID: NCT02180217

Public ClinicalTrials.gov record NCT02180217. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02180217
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
137 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 5, 2014
Primary completion
Feb 20, 2018
Completion
Dec 3, 2019
Last update posted
Jan 5, 2021

2014 – 2019

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
University of Colorado Hospital SC - LCI699C2301 Aurora Colorado 80045
Emory University School of Medicine G2304 - C2301 Atlanta Georgia 30322
Northwestern University SC - LCI699C2301 Chicago Illinois 60611
The Johns Hopkins University School of Medicine Johns Hopkins University Baltimore Maryland 21205
Massachusetts General Hospital Neuroendocrine Unit Boston Massachusetts 02114
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109
Mount Sinai School of Medicine SC - LCI699C2301 New York New York 10029
Columbia University Medical Center New York Presbyterian SC - LCI699C2301 New York New York 10032
Memorial Sloan Kettering Cancer Center New York New York 10065
Oregon Health and Science University SC LCI699C2301 Portland Oregon 97239
University of Pennsylvania Clinical Studies Unit Unniv SC Philadelphia Pennsylvania 19104
Medical College of Wisconsin MCW 2 Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02180217, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2021 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02180217 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →