A Double-blind, Randomised, 30-week Placebo-controlled Phase IV Study to Assess the Efficacy and Safety of Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
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.
• 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
• Participants with uncontrolled hypertension on stable doses of BP lowering medications (for at least 4 weeks); qualifying BP measurements by ABPM taken prior to randomisation defined as: Average of 24h ABPM SBP ≥ 135 or DBP ≥ 85 mmHg
• Participants under glucocorticoid replacement therapy can be recruited only if this therapy has been already stopped for at least seven days or 5 half-lives prior to screening, whichever was longer
• Not taking any drug therapy for CS. The following minimum periods without these medications need to be completed before baseline assessments:
‣ Steroidogenesis inhibitors (e.g. ketoconazole, metyrapone): 1 week
⁃ Mifepristone: 3 weeks
⁃ SC Pasireotide: 1 week
⁃ Pasireotide LAR: 3 months
⁃ Cabergoline: 4 weeks
• Able to take oral medication and be willing to comply with the requirements of the study