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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.
Register: EUCTR
Last refreshed on: 10 February 2014
Main ID:  EUCTR2004-001580-22-DE
Date of registration: 20/10/2004
Prospective Registration: Yes
Primary sponsor: MSD SHARP & DOHME GMBH
Public title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study
Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study
Date of first enrolment: 21/12/2004
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001580-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Germany United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Patient is at least 18 years of age.

Patient has a diagnosis of homozygous sitosterolemia, with a history of plasma sitosterol concentration of >5 mg/dL (0.13 mmol/L).

Patient has been on an on-going stable regimen of ezetimibe 10 mg daily for at least 6 months prior to visit 1.

Current treatment regimen for sitosterolemia and diet must be stable for at least 4 weeks prior to visit 1 and for the duration of the study.
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:
Patient has a condition which might pose a risk to the patient, interfere with participation in the study, or does not meet criteria for this protocol.

Patient has clinically significant lab abnormalities prior to visit 2 (ALT, AST, CPK = 3 x ULN, TSH >6 mIU/L).

Patient has the following conditions: uncontrolled cardiac arrhythmias, severe/unstable peripheral vascular disease, uncontrolled hypertension, impaired renal function, very poorly controlled Type 1 or Type 2 DM, active or chronic hepatobiliary or hepatic disease, positive for HIV.

Patient has the following conditions within 1 month of visit 1: unstable angina pectoris, symptomatic carotid disease, myocardial infarction, coronary artery bypass surgery/other invasive coronary.

Patient is on statin AND is treated with, or likely to require treatment with, an agent that has precautions or contraindications to concomitant use with the statin.
Patient is taking oral corticosteroids UNLESS patient uses as stable replacement therapy for pituitary/adrenal disease.

Patient is on a thiazide diuretic UNLESS treated with a stable regimen for at least 6 weeks prior to visit 1.

Patient has ileal bypass surgery within 3 months prior to visit 1.

Patient has a condition which might pose a risk to the patient, interfere with participation in the study, or does not meet criteria for this protocol.

Patient has clinically significant lab abnormalities prior to visit 2 (ALT, AST, CPK = 3 x ULN, TSH >6 mIU/L).

Patient has the following conditions: uncontrolled cardiac arrhythmias, severe/unstable peripheral vascular disease, uncontrolled hypertension, impaired renal function, very poorly controlled Type 1 or Type 2 DM, active or chronic hepatobiliary or hepatic disease, positive for HIV.

Patient has the following conditions within 1 month of visit 1: unstable angina pectoris, symptomatic carotid disease, myocardial infarction, coronary artery bypass surgery/other invasive coronary.

Patient is on statin AND is treated with, or likely to require treatment with, an agent that has precautions or contraindications to concomitant use with the statin.

Patient is taking oral corticosteroids UNLESS patient uses as stable replacement therapy for pituitary/adrenal disease.

Patient is on a thiazide diuretic UNLESS treated with a stable regimen for at least 6 weeks prior to visit 1.

Patient has ileal bypass surgery within 3 months prior to visit 1.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Homozygous Sitosterolemia
Intervention(s)

Trade Name: Ezetrol
Product Name: Ezetrol
Product Code: MK-0653
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10, 40-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: In patients with sitosterolemia who have been taking ezetimibe 10 mg daily for at least 6 months prior to entry, to compare the effects of adding ezetimibe 30 mg versus placebo to ongoing ezetimibe 10-mg treatment for 26 weeks on plasma sitosterol concentration.
Primary end point(s): Plasma concentrations of sitosterol, campesterol, lathosterol, desmosterol, total cholesterol, LDL-C, radiographic assessment of Achilles tendon thickness and direct measurements of non-Achilles xanthomas.
Secondary Objective: In patients with sitosterolemia who have been taking ezetimibe 10 mg daily for at least 6 months prior to entry:

1.To compare the effects of adding ezetimibe 30 mg versus placebo to ongoing ezetimibe 10-mg treatment for 26 weeks on plasma campesterol concentration.

2.To assess change in size of Achilles tendon-thickness and non-Achilles xanthomas relative to baseline after adding ezetimibe 30 mg versus placebo to ongoing treatment with ezetimibe 10 mg for 26 weeks.

3.To evaluate the safety and tolerability of ezetimibe 40 mg in patients with sitosterolemia previously treated with ezetimibe 10 mg.
Secondary Outcome(s)
Secondary ID(s)
062
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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