Trial · NCT05382156
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of osilodrostat-related adverse events and serious adverse events | 3 years of treatment with osilodrostat | Number of participants with Adverse Events and Serious Adverse Events |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Complete response rate: proportion of enrolled patients with mean Urinary Free Cortisol (mUFC) ≤ ULN |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Partial response rate: proportion of enrolled patients with ≥ 50% reduction from baseline in mean urinary free cortisol (mUFC), (but mUFC \> ULN) |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Overall response rate: proportion of enrolled patients with mean urinary free cortisol (mUFC) ≤ ULN or at least 50% reduction from baseline |
| Secondary | Changes in pituitary tumour size | at baseline before treatment start, after 6 months of treatment, then every 12 months through study completion up to three years | Actual and percentage change from baseline in pituitary tumour size |
| Secondary | Incidence of Adverse Events (Safety and Tolerability) | 3 years of treatment with osilodrostat | Incidence of adverse events and laboratory abnormalities using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale (version 5.0). |
| Secondary | Change of mean urinary free cortisol (mUFC) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in mean urinary free cortisol (mUFC) |
| Secondary | Change of Serum Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Serum Cortisol |
| Secondary | Change of Late Salivary Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Late Salivary Cortisol |
| Secondary | Change of adrenocorticotropic hormone (ACTH) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in adrenocorticotropic hormone (ACTH) |
| Secondary | Normalization of Serum Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Proportion of patients achieving normalisation of Serum Cortisol |
| Secondary | Normalization of Late Salivary Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Proportion of patients achieving normalisation of Late Salivary Cortisol |
| Secondary | Normalization of adrenocorticotropic hormone (ACTH) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Proportion of patients achieving normalisation of adrenocorticotropic hormone (ACTH) |
| Secondary | Change in Fasting Glucose | at baseline before treatment start, then every 3 months through study completion up to three years | Actual and percentage change from baseline in fasting glucose |
| Secondary | Change in HbA1c | at baseline before treatment start, then every 3 months through study completion up to three years | Actual and percentage change from baseline in HbA1c |
| Secondary | Change in Fasting Lipid Profile | at baseline before treatment start, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Fasting Lipid Profile |
| Secondary | Change in Serum Insulin | at baseline before treatment start, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Serum Insulin |
| Secondary | Change in Blood Pressure | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Blood Pressure |
| Secondary | Change in Body Weight | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Body Weight |
| Secondary | Change in Body Mass Index (BMI) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Body Mass Index (BMI) |
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/NCT05382156/registered