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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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28 February 2019 |
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Main ID: |
EUCTR2006-006742-34-GB |
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Date of registration:
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03/06/2007 |
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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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The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.
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Scientific title:
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The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis. |
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Date of first enrolment:
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20/12/2007 |
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Target sample size:
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70 |
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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:2006-006742-34 |
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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: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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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:
1. All patients with diagnosis of PBC.
2. Aged over 19yo.
3. Male and Female.
4. Able to give consent
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:
1. Patients with other causes of liver disease.
2. Patients who are recruited and taking part in another reseach study.
3. Patients who are unable to give informed consent.
a. Adults with learning disabilities
b. Children under 16
c. Females who are pregnant or lactating.
d. Adults who are unconscious or very severely ill
e. Adults who have a terminal illness
f. Patients with a diagnosis of cancer.
g. Adults in emergency situations
h. Adults with serious mental illness
i. Adults with dementia
j. Prisoners
4. Patients on statin, fibrate, ciclosporin
5. Patients with rare hereditary problems of galactose intolerance
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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primary biliary cirrhosis
MedDRA version: 9.1
Level: LLT
Classification code 10036680
Term: Primary biliary cirrhosis
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Intervention(s)
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Trade Name: Ezetrol
Product Name: Ezetimibe
Product Code: EZT
Pharmaceutical Form: Tablet
INN or Proposed INN: EZETIMIBE
CAS Number: 163222-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10mg-
Trade Name: pyridoxine 10mg BP
Product Name: pyridoxine 10mg
Product Code: A11HA02
Pharmaceutical Form: Tablet
INN or Proposed INN: PYRIDOXINE
CAS Number: 65236
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10MG-
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Primary Outcome(s)
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Main Objective: The effect of ezetimibe on cholesterol levels. Previous studies have shown that ezetimibe 10mg reduces cholesterol levels by 18%.
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Secondary Objective: To establish the effects, toxicity and therefore safety of ezetimibe in patients with primary biliary cirrhosis by monitoring liver function enzymes. Ezetimibe has been found to produce non-significant changes in liver enzymes.
The effect of pyridoxine on haemoglobin concentration. Because previous pyridoxine should increase haemoglobin only in patients who have a deficiency, we would expect only occasional, individual changes. The effect on the group mean haemoglobin is likely to be small (<0.5 g/100ml).
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Primary end point(s): In the general population, previous drug trials showed ezetimibe produces a decrease in plasma total choleserol concentration of ~18%. Reductions of even 5% are thought to be clinically useful and can be acheived by lifestyle intervention. Our primary end-point is the reduction in plasma total cholesterol concentration achieved by ezetimibe in patients with PBC.
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Secondary ID(s)
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ezetimibe27
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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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