Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01838551 · ClinicalTrials.gov registry record · Phase 3
Treatment for Endogenous Cushing's Syndrome
A Phase 3 study of Endogenous Cushing's Syndrome, sponsored by Cortendo AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT01838551: Completed Phase 3 study of Endogenous Cushing's Syndrome, sponsored by Cortendo AB.
NCT01838551 is a Phase 3 study of Endogenous Cushing's Syndrome that has completed, run by Cortendo AB. The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838551, a Phase 3 study of Endogenous Cushing's Syndrome, has completed, sponsored by Cortendo AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS m
Conditions Studied
Interventions
- DRUG Levoketoconazole
Study Locations (20)
Other
- University Hospitals Leuven Department of Endocrinology - Leuven
- University Specialized Hospital for Active Treatment in Endocrinology (USHATE) - Sofia
- Vseobecna fakultni nemocnice v Praze - III. Interni klinika VFN a 1. LF UK - Prague
- Aarhus University Hospital - Aarhus
- Rigshospitalet,Copenhagen University Hospital - Copenhagen
- Hôpital de la CONCEPTION, Service d'Endocrinologie, Diabète et Maladies Métaboliques - Marseille
- Med Clinic I - University of Lueback - Lübeck
- Bnail Zion Medical Center Institute of Endocrinology & Metabolism - Haifa
- Institute of Endocrinology & Metabolism, Rabin Medical Center - Petah Tikva
- Sourasky Medical Center, Endocrinology & Metabolism - Tel Aviv
California
- UCLA School of Medicine - Los Angeles
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- University of Michigan Medical Center - Ann Arbor
New Mexico
- University of New Mexico HSC - Albuquerque
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-11 |
| Phase | Phase 3 |
What the finished NCT01838551 record still lists
NCT01838551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Endogenous Cushing's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Levoketoconazole is the first listed.
NCT01838551 names 20 study sites across 11 states, led by Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT01838551 about?
NCT01838551 is a clinical study titled "Treatment for Endogenous Cushing's Syndrome". 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 level...
What is the current status of trial NCT01838551?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2014-08. Estimated completion is 2018-11.
What conditions does trial NCT01838551 study?
This clinical trial studies the following conditions: Endogenous Cushing's Syndrome.
What interventions are being tested in trial NCT01838551?
The interventions under investigation include: Levoketoconazole (DRUG).
Who is sponsoring clinical trial NCT01838551?
This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01838551 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Michigan, New Mexico. 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 NCT01838551's enrollment target sits among peer trials
94 1719th of 2000 higher than 279 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03747146 · 94 participants · NA
Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service
- NCT04061421 · 94 participants · Phase 1
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
- NCT04205968 · 94 participants · Phase 2
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
- NCT04464759 · 94 participants · Phase 1
A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia