Status:
COMPLETED
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
Lead Sponsor:
Corcept Therapeutics
Conditions:
Hypercortisolism
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma o...
Detailed Description
The primary outcome measures of the study are 1) to assess the efficacy of relacorilant based on blood pressure control at Week 22 compared with placebo, and 2) to assess the safety of relacorilant ba...
Eligibility Criteria
Inclusion
- Shows lack of cortisol suppression on dexamethasone suppression test
- Suppressed or low early-morning adrenocorticotropic hormone (ACTH) levels
- A radiologically confirmed adrenal lesion
- Has IGT or DM
- Has uncontrolled HTN
Exclusion
- Has severe, uncontrolled HTN
- Has poorly controlled DM
- Has DM Type 1
- Has significantly abnormal liver test results or severe renal insufficiency
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2024
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04308590
Start Date
July 27 2020
End Date
September 19 2024
Last Update
September 4 2025
Active Locations (45)
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1
Site 27
Birmingham, Alabama, United States, 35294
2
Site 17
Stanford, California, United States, 94305
3
Site 53
Torrance, California, United States, 90502
4
Site 07
Atlanta, Georgia, United States, 30318