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NCT03708900 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
A Phase 2 study of Cushing Syndrome, sponsored by Recordati Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 15
- Study locations
NCT03708900: Recruiting Phase 2 study of Cushing Syndrome, sponsored by Recordati Group.
NCT03708900 is a Phase 2 study of Cushing Syndrome that is actively recruiting participants, run by Recordati Group. The registered enrollment target is 12 participants, below the 179-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03708900, a Phase 2 study of Cushing Syndrome, is actively recruiting participants, sponsored by Recordati Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 15
- Study locations
Study Summary
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
Primary Outcome
evaluate the pharmacokinetics (PK) of osilodrostat in children and adolescents of 2 to less than 18 years of age with Cushing's Syndrome
Conditions Studied
Interventions
- DRUG LCI699
Study Locations (15)
Other
- Multiprofile Hospital for Active Treatment Sveta Marina EAD - Varna
- Hospital Necker Enfants Malades - Paris
- Robert Debre Hospital - Paris
- CHU Bicetre APHP Paris Saclay - Paris
- Ospedale Bambino Gesu - Roma
- University Clinical Center Ljubljana - Ljubljana
- Alder Hey Childrens NHS Foundation Trust - Liverpool
- The Royal London Childrens Hospital - London
California
- University of California San Francisco UCSF - San Francisco
Florida
- ABMED Clinical Research Corp - Cape Coral
Illinois
- Ann & Robert H. Lurie Children's Hospital - Chicago
Maryland
- National Institute of Child Health and Human Development - Bethesda
Texas
- Texas Valley Clinical Research - Weslaco
Brussels Capital
- UZ Brussel - Jette
PI
- Aziendal Ospedaliero Universitaria Pisana Presidio Ospedale di Cisanello - Pisa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2027-07-21 |
| Phase | Phase 2 |
What NCT03708900 shows while recruiting
NCT03708900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 179-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Cushing Syndrome appearing as the primary indexed condition, and to 1 intervention - of which LCI699 is the first listed.
NCT03708900 lists 15 locations in 8 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03708900 about?
NCT03708900 is a clinical study titled "Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome". Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
What is the current status of trial NCT03708900?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-04-28. Estimated completion is 2027-07-21.
What conditions does trial NCT03708900 study?
This clinical trial studies the following conditions: Cushing Syndrome.
What interventions are being tested in trial NCT03708900?
The interventions under investigation include: LCI699 (DRUG).
Who is sponsoring clinical trial NCT03708900?
This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03708900 being conducted?
This trial has 15 study locations across California, Florida, Illinois, Maryland, Texas. 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 NCT03708900's enrollment target sits among peer trials
12 10th of 9 the lowest 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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