Trial · NCT03708900
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
NCT03708900, Phase 2, Recruiting, RECORDATI GROUP
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome. Trials, record NCT03708900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03708900
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
- NCT number
- NCT03708900
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 12 participants, estimated
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Cushing Syndrome
- Interventions
- LCI699
- First posted
- 2018-10-17
- Last updated
- 2026-03-27
- Other registries' IDs
- eudract:2018-001522-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Study: Evaluate the pharmacokinetics (PK) of osilodrostat using Pharmacokinetic parameters of osilodrostat up to Week 12 in children and adolescents 2 to less than 18 years of age with Cushing's Syndrome | up to Week 12 | evaluate the pharmacokinetics (PK) of osilodrostat in children and adolescents of 2 to less than 18 years of age with Cushing's Syndrome |
| Secondary | Core Study: Percentage of patients with normal mean urinary free cortisol (mUFC) at week 3, 6, 9 and week 12 (or end of treatment) | week 3, 6, 9 and week 12 (or end of treatment) | The assessment in the core period will be done by taking the percentage of patients with normal mUFC at week 6 and week 12 (or end of treatment). |
| Secondary | Core Study: Change from baseline in mean urinary free cortisol (mUFC) during the core study period | week 3, 6, 9 and week 12 (or end of treatment) | The assessment will be done by comparison of change from the baseline in mUFC during core study period on patients |
| Secondary | Extension: Efficacy of osilodrostat as measured by mUFC levels up to Month 12 | up to month 12 | The assessment of efficacy of osilodrostat to be measured by change in baseline of mUFC levels up to 12 months on patients |
| Secondary | Extension: Efficacy of osilodrostat as measured by mUFC levels up to Month 12 | up to month 12 | The assessment of efficacy of osilodrostat to be measured byproportion of patients with normal mUFC levels at each visit up to 12 months |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat. | week 3, 6, 9 and week 12 (or end of treatment) | Change from baseline in weight in core period |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat up to 12 months | up to 12 months | Change from baseline in weight at each visit in extension period |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat.assessment of the pharmacodynamics, safety and tolerability of osilodrostat. | week 3, 6, 9 and week 12 (or end of treatment) | Change from baseline in body mass index in core period |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat.assessment of the pharmacodynamics, safety and tolerability of osilodrostat. | up to 12 months | Change from baseline in body mass index at each visit in extension period |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat. | week 3, 6, 9 and week 12 (or end of treatment) | Change from baseline in height in core period |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03708900
GET https://conductscience.org/api/trials/v1/NCT03708900/registered