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NCT03277690 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

A Phase 3 study of Endogenous Cushing's Syndrome, sponsored by Cortendo AB.

Completed
Registry status
Phase 3
Development phase
84
Enrollment target
20
Study locations

NCT03277690 is a Phase 3 study of Endogenous Cushing's Syndrome that has completed, run by Cortendo AB. The registered enrollment target is 84 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT03277690, a Phase 3 study of Endogenous Cushing's Syndrome, has completed, sponsored by Cortendo AB.

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

Study Summary

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

Interventions

  • DRUG Placebo
  • DRUG Levoketoconazole

Study Locations (20)

Other

  • Alexandovska University Hospital, Clinic of Endocrinology & Metabolic Diseases - Sofia
  • University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD Clinic of Endocrinology and Metabolic Diseases - Sofia
  • University Specialized Hospital for Active Treatment in Endocrinology (USHATE) I Klinika - Sofia
  • Rigshospitalet, Copenhagen University Hospital, Endocrinology Department - Copenhagen
  • Evangelismos Athens General Hospital, Department of Endocrinology - Athens
  • General Hospital of Athens 'G. Gennimatas', Department of Endocrinology-Diabetes Centre - Athens

California

  • Keck Medical Center University of Southern California HCII, Internal Medicine - Keck Hospital - Los Angeles
  • Cedars-Sinai Medical Center, Cedars-Sinai Pituitary Center - Los Angeles
  • UCLA School of Medicine, Medicine/Endocrinology Department - Los Angeles

New York

  • Columbia University, College of P&S Medicine/Neuro-endocrine Unit - New York
  • Memorial Sloan Kettering Cancer Center, Endocrinology - New York

Florida

  • The Center for Diabetes and Endocrine Care - Fort Lauderdale

Georgia

  • Emory University, Neurosurgery - Atlanta

Illinois

  • Northwestern University, Medicine - Endocrinology - Chicago

Maryland

  • Johns Hopkins University, Endocrinology Department - Baltimore

Michigan

  • University of Michigan, Comprehensive Endocrine Research, Internal Medicine - MEND - Ann Arbor

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2017-09-26
Est. Completion 2020-08-31
Phase Phase 3

Sponsor

Cortendo AB

6 total trials

What the Registry Record Tells You About NCT03277690

The ClinicalTrials.gov registry entry for NCT03277690 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cortendo AB, which has 6 total studies on file at ClinicalTrials.gov.

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

NCT03277690 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT03277690 about?

NCT03277690 is a clinical study titled "A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.". This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole...

What is the current status of trial NCT03277690?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2017-09-26. Estimated completion is 2020-08-31.

What conditions does trial NCT03277690 study?

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

What interventions are being tested in trial NCT03277690?

The interventions under investigation include: Placebo (DRUG), Levoketoconazole (DRUG).

Who is sponsoring clinical trial NCT03277690?

This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03277690 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Maryland. 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.