Trial · NCT03708900
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | assessment of the pharmacodynamics, safety and tolerability of osilodrostat. | up to 12 months | Change from baseline in height at each visit in extension period |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03708900/registered