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Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 3 of 15 sitesv19
  2. Primary and study completion dates: Nov 21, 2025 to Jul 21, 2027
    • Study sites: 12 to 15
    v18
  3. Site details revised at 8 of 12 sitesv17
  4. Primary endpoints: 2 to 1v16 Show 4 more changesShow less
    • Eligibility criteria expanded, about 444 words
    • Secondary endpoints: 3 to 10
    • Site details revised at 1 of 12 sites
    • Study title revised
  5. Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 10 to 12v14
  2. Primary completion date: Feb 21, 2023 to Nov 21, 2025
    • Study sites: 7 to 10
    • Study completion date: Nov 29, 2023 to Nov 21, 2025
    v13
  3. Lead sponsor: Novartis Pharmaceuticals to RECORDATI GROUP
    • Start date changed from estimate of Oct 30, 2020 to Apr 28, 2021
    • Study sites: 6 to 7
    • Study description expanded, about 101 words
    v12
  4. Study sites: 5 to 6v11
  5. Primary completion date: Aug 22, 2022 to Feb 21, 2023
    • Start date: Apr 30, 2020 to Oct 30, 2020
    • Study completion date: May 30, 2023 to Nov 29, 2023
    v10
  6. Study sites: 4 to 5v9
  7. Primary completion date: Feb 21, 2022 to Aug 22, 2022
    • Start date: Oct 31, 2019 to Apr 30, 2020
    • Study sites: 3 to 4
    • Study completion date: Nov 29, 2022 to May 30, 2023
    v8
  8. Study sites: 2 to 3v7
  9. Start date: Aug 30, 2019 to Oct 31, 2019
    • Primary completion date: Dec 21, 2021 to Feb 21, 2022
    • Study completion date: Sep 28, 2022 to Nov 29, 2022
    v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v5
  11. Start date: Jul 1, 2019 to Aug 30, 2019
    • Primary completion date: Oct 20, 2021 to Dec 21, 2021
    • Study completion date: Jul 28, 2022 to Sep 28, 2022
    v4
  12. Enrollment target: 20 to 12
    • Primary completion date: Mar 22, 2021 to Oct 20, 2021
    • Start date: Jan 31, 2019 to Jul 1, 2019
    • Study completion date: Jan 7, 2022 to Jul 28, 2022
    v3
  13. Start date: Dec 5, 2018 to Jan 31, 2019
    • Study completion date: Jun 24, 2021 to Jan 7, 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
Trial Details
NCT Number NCT03708900
Lead Sponsor RECORDATI GROUP
Conditions
(from sponsor)		 Cushing Syndrome
Related terms Cushing Syndrome, Pituitary Diseases
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov