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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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2007-007604-15-GB |
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Date of registration:
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21/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings
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Scientific title:
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A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings |
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Date of first enrolment:
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03/03/2009 |
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Target sample size:
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6 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007604-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- male and over 18 years old or postmenopausal women
- Patients have adrenal incidentaloma with benign characteristics as assessed on CT or MRI
- Patients lack clinical features classically associated with Cushing's Syndrome
- Patients have evidence of excess cortisol as shown by lack of supression of serum cortisol using standard routine tests
- Patients are on stable antihypertensive and diabetic medication for two months prior to study entry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria include:
- evidence of local or systemic malignancy
- overt Cushing's Syndrome
- servere uncontrolled diabetes mellitus or hypertension
- pregnancy
- clinically significantly impaired cardiovascular function, severe liver disease, significantly impaired renal function
- uncontrolled severe active infection
- treatment with approved or experimental drugs which work on the adrenal glands
- in women a known history of uterine problems
- a requirement for steroids for existing disease
- impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Sub Clinical Cushing's Syndrome
MedDRA version: 9.1
Level: PT
Classification code 10011652
Term: Cushing's syndrome
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Intervention(s)
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Trade Name: mifedren
Product Name: HRA052015 (mifepristone)
Product Code: HRA052015
Pharmaceutical Form: Tablet
INN or Proposed INN: MIFEPRISTONE
CAS Number: 84371653
Current Sponsor code: HRA052015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): the primary outcome measures are:
1) ambulatory and resting blood pressure are 8 weeks
2) 2-hour glucose tolerance at 8 weeks
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Main Objective: The principle research question is, does mifepristone, a glucocorticoid (steroid) receptor antagonist, improve cardiovascular and biochemical profiles in patients with sub-clinical Cushing's Syndrome, a condition where an abnormally high level of steroids (cortisol) are being produced?
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Secondary Objective: Are there biochemical markers which predict or explain the response observed with mifepristone in patients with sub-clinical Cushing's Syndrome?
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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