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NCT02180217 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Cushing's Disease, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
137
Enrollment target
20
Study locations

NCT02180217 is a Phase 3 study of Cushing's Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 137 participants, above the 104-participant average among 5 other Cushing's Disease trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT02180217, a Phase 3 study of Cushing's Disease, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
137 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Cushing's Disease

Interventions

  • DRUG osilodrostat
  • DRUG LCI699 matching placebo

Study Locations (20)

New York

  • Mount Sinai School of Medicine SC - LCI699C2301 - New York
  • Columbia University Medical Center New York Presbyterian SC - LCI699C2301 - New York
  • Memorial Sloan Kettering Cancer Center - New York

Buenos Aires

  • Novartis Investigative Site - CABA
  • Novartis Investigative Site - CABA

Other

  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Sofia

Quebec

  • Novartis Investigative Site - Montreal
  • Novartis Investigative Site - Sherbrooke

Colorado

  • University of Colorado Hospital SC - LCI699C2301 - Aurora

Georgia

  • Emory University School of Medicine G2304 - C2301 - Atlanta

Illinois

  • Northwestern University SC - LCI699C2301 - Chicago

Maryland

  • The Johns Hopkins University School of Medicine Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2014-10-06
Est. Completion 2019-12-04
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT02180217

The ClinicalTrials.gov registry entry for NCT02180217 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 104-participant average among 5 other Cushing's Disease trials with a reported enrollment target (32% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cushing's Disease appearing as the primary indexed condition, and to 2 interventions - of which osilodrostat is the first listed.

NCT02180217 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Buenos Aires, Other.

Frequently Asked Questions

What is clinical trial NCT02180217 about?

NCT02180217 is a clinical study titled "Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease". 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, do...

What is the current status of trial NCT02180217?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2014-10-06. Estimated completion is 2019-12-04.

What conditions does trial NCT02180217 study?

This clinical trial studies the following conditions: Cushing's Disease.

What interventions are being tested in trial NCT02180217?

The interventions under investigation include: osilodrostat (DRUG), LCI699 matching placebo (DRUG).

Who is sponsoring clinical trial NCT02180217?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02180217 being conducted?

This trial has 20 study locations across Colorado, Georgia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.