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NCT03621280 · ClinicalTrials.gov registry record · Phase 3
Open-label Treatment in Cushing's Syndrome
A Phase 3 study of Cushing Syndrome and Cushing Disease, sponsored by Cortendo AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT03621280: Completed Phase 3 study of Cushing Syndrome and Cushing Disease, sponsored by Cortendo AB.
NCT03621280 is a Phase 3 study of Cushing Syndrome and Cushing Disease that has completed, run by Cortendo AB. The registered enrollment target is 51 participants, below the 175-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03621280, a Phase 3 study of Cushing Syndrome and Cushing Disease, has completed, sponsored by Cortendo AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
Primary Outcome
Proportions of participants with mUFC: 1) Less or equal to the ULN of the reference range, 2) Above the ULN to 1.5x the ULN, and 3) Above 1.5x the ULN.
Conditions Studied
Interventions
- DRUG Levoketoconazole
Study Locations (20)
Other
- Sveti Georgy University Hospital Clinic of Endocrinology and Metabolic Diseases - Plovdiv
- Alexandovska University Hospital - Sofia
- University Specialized Hospital for Active Treatment in Endocrinology - Sofia
- APHM Hôpital de la Conception - Marseille
- General Hospital of Athens Evangelismos Department of Endocrinology and Diabete - Athens
- Hippokration General Hospital Endocrinology and Diabetes Department - Thessaloniki
- Semmelweis Egyetem II. Belgyógyászati Klinika - Budapest
- Bnai Zion Medical Center Endocrinology Institute - Haifa
- Rabin Medical Center, Beilinson Campus - Petah Tikva
- Tel Aviv-Sourasky Medical Center Institute Endocrinology Metabolism & Hypertension - Tel Aviv
- Clinica Endocrinologia malattie del Metabolismo - Ancona
- AOU Policlinico G. Martino Sezione di Endocrinologia - Messina
New York
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Florida
- The Center for Diabetes and Endocrine Care - Fort Lauderdale
Georgia
- Emory University - Atlanta
Missouri
- Washington University School of Medicine - St Louis
New Mexico
- University of New Mexico HSC - HSC Sponsored Projects Office - Albuquerque
Ohio
- Cleveland Clinic - Cleveland
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 3 |
What the finished NCT03621280 record still lists
NCT03621280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 175-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Cushing Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Levoketoconazole is the first listed.
NCT03621280 names 20 study sites across 8 states, led by Other, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT03621280 about?
NCT03621280 is a clinical study titled "Open-label Treatment in Cushing's Syndrome". This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
What is the current status of trial NCT03621280?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2019-01-07. Estimated completion is 2022-12-31.
What conditions does trial NCT03621280 study?
This clinical trial studies the following conditions: Cushing Syndrome, Cushing Disease.
What interventions are being tested in trial NCT03621280?
The interventions under investigation include: Levoketoconazole (DRUG).
Who is sponsoring clinical trial NCT03621280?
This trial is sponsored by Cortendo AB, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03621280 being conducted?
This trial has 20 study locations across Florida, Georgia, Missouri, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cushing 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 NCT03621280's enrollment target sits among peer trials
51 7th of 9 higher than 3 of 9 other Cushing Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cushing Syndrome 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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