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Treatment for Endogenous Cushing's Syndrome

NCT01838551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-04-19

Study results available
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Summary

The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.

Conditions

  • Endogenous Cushing's Syndrome

Interventions

DRUG

Levoketoconazole

Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole

Sponsors & Collaborators

  • Cortendo AB

    lead INDUSTRY

Principal Investigators

  • Fredric J Cohen, MD · Cortendo AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-04-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Serbia
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01838551 on ClinicalTrials.gov