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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: Completed Phase 3 study of Endogenous Cushing's Syndrome, sponsored by Cortendo AB.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Urinary free cortisol (UFC) level measurement: Loss of therapeutic response is inferred based on mUFC from three 24-hour UFC measurements obtained at any visit from second through final Randomized Withdrawal Phase visits (RW1 through RW5 inclusive) when: (1) mUFC is above 1.5X the ULN of the central laboratory's reference range, OR (2) mUFC is more than 40% above the baseline (RW0) value, if the RW0 value is above the ULN (i.e. \>1.0X ULN)1, OR (3) an early rescue criterion is met.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-09-26 |
| Est. Completion | 2020-08-31 |
| Phase | Phase 3 |
What the finished NCT03277690 record still lists
NCT03277690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Endogenous Cushing's Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03277690's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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