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
Qualifiers
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
Treatments tested in this trial
- Osilodrostat
- Placebo
Treatment groups
63 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov