Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRECORDATI GROUP
About this trial
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥ 18 years of age
Able to provide and have provided signed written informed consent prior to study participation
Diagnosis of endogenous Cushing's Syndrome
mUFC values from two 24h urinary collections > ULN and ≤ 2x ULN
Disqualifiers
Previously treated with osilodrostat less than 12 weeks prior to start of screening
Known hypersensitivity to osilodrostat
Presence of any severe and/or uncontrolled medical condition or other conditions that could affect participation in the study
Participants who are scheduled for a surgery to treat CS within 32 weeks of randomisation to the study drug
Trial design
Design model
Parallel
Treatments tested in this trial
Osilodrostat
DrugOsilodrostat tablets 1 mg and 5 mg for oral useOsilodrostat tablets 1 mg and 5 mg for oral use.During the 18-week titration phase, the dose of the medication will be titrated every 3 weeks based on the cortisolaemic and clinical response to treatment. An independent endocrinologist titration committee will be applied to provide recommendations on dose-titration based on biochemical and clinical response. At the end of the 18-week dose titration phase, participants will enter a 12-week dose maintenance phase, which is also blinded. They will continue with the dose they were receiving at the end of the dose titration phase, unless there is a need to down-titrate or to stop the study medication for safety purposes.
Placebo
Drugmatching placebo
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: LCI699 (osilodrostat)Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the efficacy of osilodrostat on the proportion of participants with normalisation of urinary-free cortisol (UFC)
Proportion of participants with normalisation of the 24h-mUFC (as measured by the mean of the UFC concentrations of two 24-h urine collections ≤1xULN)
Time frame
30 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: