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NCT01331239 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of LCI699 in Cushing's Disease Patients

A Phase 2 study of Cushing Disease and Cushing's Disease, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target
10
Study locations

NCT01331239 is a Phase 2 study of Cushing Disease and Cushing's Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants, below the 389-participant average among 8 other Cushing Disease trials with a reported enrollment target (92% lower). The trial reports 10 study locations across 6 states.

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The verdict

NCT01331239, a Phase 2 study of Cushing Disease and Cushing's Disease, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target
10
Study locations

Study Summary

This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease. In addition, this study evaluated the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed by a 12 month long term optional extension. A second extension provided patients who were clinically benefitting from LCI699 an opportunity to continue to have access to the drug until LCI699 was commercially available and reimbursed or through the availability of a local access program.

Conditions Studied

Cushing Disease Cushing's Disease

Interventions

  • DRUG LCI699

Study Locations (10)

Other

  • Novartis Investigative Site - Le Kremlin-Bicêtre
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Ancona
  • Novartis Investigative Site - Naples
  • Novartis Investigative Site - Chiba

Illinois

  • Northwestern University Endo, Metabolism and Molecular - Chicago

Massachusetts

  • Massachusetts General Hospital Neuroendocrine Unit - Boston

Ohio

  • Cleveland Clinic Foundation - Cleveland

Oregon

  • Oregon Health and Science University SC - Portland

Hokkaido

  • Novartis Investigative Site - Sapporo

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2011-03-23
Est. Completion 2019-10-22
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01331239

The ClinicalTrials.gov registry entry for NCT01331239 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 389-participant average among 8 other Cushing Disease trials with a reported enrollment target (92% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cushing Disease appearing as the primary indexed condition, and to 1 intervention - of which LCI699 is the first listed.

NCT01331239 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Other, Illinois, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01331239 about?

NCT01331239 is a clinical study titled "Safety and Efficacy of LCI699 in Cushing's Disease Patients". This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease. In addition, this study evaluated the long term efficacy and safety of LCI699 including an additional 12 week of treatment followed...

What is the current status of trial NCT01331239?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-03-23. Estimated completion is 2019-10-22.

What conditions does trial NCT01331239 study?

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

What interventions are being tested in trial NCT01331239?

The interventions under investigation include: LCI699 (DRUG).

Who is sponsoring clinical trial NCT01331239?

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

Where is trial NCT01331239 being conducted?

This trial has 10 study locations across Illinois, Massachusetts, Ohio, Oregon, Hokkaido. 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.