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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00936741 |
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Date of registration:
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09/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome
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Scientific title:
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An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00936741 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Coleman Gross, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Corcept Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study
C-1073-400 (NCT00569582).
- In the opinion of the Investigator, are expected to maintain clinical benefit from
mifepristone.
- Women of childbearing potential have a negative serum pregnancy test at Entry.
- Women of childbearing potential must be willing to use non-hormonal, medically
acceptable methods of contraception during the study.
- Are able to provide written informed consent
- Are able to return to the investigative site to complete the study evaluations
outlined in the protocol.
- Will not use systemic estrogens during the study.
Exclusion Criteria:
- Have an acute or unstable medical problem, which could be aggravated by mifepristone
treatment.
- Are taking medications within 14 days of the Entry visit that a) have a large first
pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic
margin; and/or b) are strong CYP3A4 inhibitors.
- Female patients of reproductive potential, who are pregnant or who are unable or
unwilling to use medically acceptable, non-hormonal methods of contraception during
the study.
- Have received investigational treatment (drug, biological agent or device) other than
CORLUX (mifepristone) within 30 days of Entry
- Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
- Have uncorrected hypokalemia (potassium level of <3.5 mEq/L) at Entry. Spironolactone
or eplerenone is allowed to control hypokalemia.
- Postmenopausal women with a history of endometrial hyperplasia with atypia or
pathological features consistent with endometrial carcinoma.
- Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved
after induction of menstrual bleeding with progesterone.
- Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
- Any woman with an intact uterus who has a hemorrhagic disorder or is being treated
with an anticoagulant (e.g. warfarin, heparin).
- Have renal failure as defined by a serum creatinine of =2.2 mg/dL.
- Elevated total bilirubin >1.5 ULN, elevated ALT or AST =3X the upper limit of normal.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cushing's Syndrome
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Intervention(s)
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Drug: mifepristone
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Primary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: Up to three years.]
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Secondary Outcome(s)
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The Long-term Benefit of Mifepristone Treatment in Cushing's Syndrome as Measured by Changes in the Score on the Physician's Global Assessment of Disease Severity
[Time Frame: Up to three years.]
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Secondary ID(s)
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C-1073-415
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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