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Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome

NCT07247162 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-12-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Osilodrostat

Osilodrostat 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.

DRUG

Placebo

matching placebo

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-05-31
Completion
2028-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07247162 on ClinicalTrials.gov