|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 April 2024 |
|
Main ID: |
NCT03604198 |
|
Date of registration:
|
01/05/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
|
|
Scientific title:
|
An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome |
|
Date of first enrolment:
|
May 7, 2018 |
|
Target sample size:
|
75 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03604198 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Austria
|
Bulgaria
|
Canada
|
Germany
|
Israel
|
Italy
|
Netherlands
|
Poland
|
|
Romania
|
Spain
|
United States
| | | | | |
|
Contacts
|
|
Name:
|
Katherine Araque, MD, MSCR |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Corcept Therapeutics |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Major Inclusion Criteria:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing
syndrome with at least 80% compliance with the dosing schedule.
- According to the Investigator's opinion will benefit from continuing treatment
with relacorilant
Exclusion Criteria:
- Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage = 4 renal failure
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cushing Syndrome
|
|
Intervention(s)
|
|
Drug: relacorilant
|
|
Primary Outcome(s)
|
|
Long-term safety of relacorilant
[Time Frame: 36 months]
|
|
Secondary ID(s)
|
|
CORT125134-452
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|