Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000374561
Ethics application status
Approved
Date submitted
22/08/2006
Date registered
28/08/2006
Date last updated
7/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
VYTUL
Scientific title
A multi-centre, randomised, open-label parallel groups study comparing the effectiveness and safety of treatment with Vytorin (Ezetimibe and Simvastatin) versus Lipitor (Atorvastatin) in subjects with a history of coronary heart disease and/or diabetes mellitus with uncontrolled lipids on statin therapy.
Universal Trial Number (UTN)
Trial acronym
VYTUL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 1342 0
Condition category
Condition code
Metabolic and Endocrine 1430 1430 0 0
Diabetes
Cardiovascular 1431 1431 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the study will be approximately 8 weeks involving 4 visits. Randomisation to treatment groups: Vytorin 10/40 (Ezetimibe 10mg /Simvastatin 40mg) ; both these medications are registered in Australia.
Intervention code [1] 1269 0
Treatment: Drugs
Comparator / control treatment
Lipitor (Atorvastatin 80 mg) daily orally for six weeks
Control group
Active

Outcomes
Primary outcome [1] 1956 0
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of Low density lipoprotein cholesterol (LDL-C) at endpoint
Timepoint [1] 1956 0
After 6 weeks of treatment
Secondary outcome [1] 3427 0
1. the percentage of participants who achieve the target LDL-C concentration of < 2.0 mmol/L.
Timepoint [1] 3427 0
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily after 6 weeks of treatment.
Secondary outcome [2] 3428 0
2. change in the concentrations of each of the following parameters: total cholesterol, High density lipoprotein cholesterol (HDL-C), LDL-C/HDL ratio, Triglycerides (TG), apolipoprotein B (apoB) and non-HDL cholesterol.
Timepoint [2] 3428 0
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily after 6 weeks of treatment.
Secondary outcome [3] 3429 0
3. safety and tolerability with respect to Creatine Kinase (CK), Aspartate aminotransferase (AST), Alanine amino transferase (ALT) concentrations and incidence of both Non Serious Adverse and Serious Adverse Events.
Timepoint [3] 3429 0
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily after 6 weeks of treatment.

Eligibility
Key inclusion criteria
Capable of and willing to sign written informed consent- Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg- Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L- Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled diabetes, defined by a measured HbA1c > 9% as measured at Visit 1-Has alanine aminotransferase (ALT) > 1.5 times Upper Limit of Normal (ULN) as measured at Visit 1- Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at Visit 1-Has creatine kinase (CK) > 1.5 times ULN as measured at Visit 1- Has triglycerides (TG) > 4.5 mmol/L as measured at Visit 1- Has evidence of renal impairment with a serum creatinine > 200 µmol/L as measured at Visit 1- Has known drug or alcohol dependency within 6 months prior to Visit 1-A woman receiving hormonal therapy, including hormone replacement, anyestrogen antagonist/agonist, or oral contraceptives, who have not beenmaintained on a stable dose and regimen for at least 8 weeks and are willingto continue the same regimen for the duration of the study.- A woman of childbearing potential (includes women who are less than 1 yearpostmenopausal or not surgically sterile) not using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condomin combination with spermicide)- Women who are pregnant or breast feeding- Any condition or situation which, in the opinion of the investigator, might pose arisk to the subject or interfere with participation in the studyProhibited Medication for the Duration of the Study- Medications taken within 5 weeks prior to Visit 1 (Screening Visit) including: macrolide antibiotics, azole antifungals, fibric acid derivatives, niacin- Other medication as listed in the product information sheets for ezetimibe/simvastatin and atorvastatin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block 1:1 randomisation stratified by site, block size not disclosed to investigators
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1562 0
Commercial sector/Industry
Name [1] 1562 0
Merck Sharp & Dohme Australia
Country [1] 1562 0
Australia
Funding source category [2] 1563 0
Commercial sector/Industry
Name [2] 1563 0
Schering-Plough Pty. Limited
Country [2] 1563 0
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Australia & Schering-Plough Pty. Limited
Address
Country
Australia
Secondary sponsor category [1] 1374 0
University
Name [1] 1374 0
Monash University Dept of Epidemiology & Preventive Medicine,
Address [1] 1374 0
Country [1] 1374 0
Australia
Secondary sponsor category [2] 1375 0
Government body
Name [2] 1375 0
CCRE in Therapeutics
Address [2] 1375 0
Country [2] 1375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2994 0
Monash University Department of Epidemiology & Preventive Medicine CCRE in Therapeutics
Ethics committee address [1] 2994 0
Ethics committee country [1] 2994 0
Australia
Date submitted for ethics approval [1] 2994 0
Approval date [1] 2994 0
Ethics approval number [1] 2994 0
Ethics committee name [2] 2995 0
Clinical Trials Centre Caulfield General Medical Centre-Alfred Ethics Committee
Ethics committee address [2] 2995 0
Ethics committee country [2] 2995 0
Australia
Date submitted for ethics approval [2] 2995 0
Approval date [2] 2995 0
31/07/2006
Ethics approval number [2] 2995 0
162/06

Summary
Brief summary
To determine if the introduction of Vytorin will be more effective than increasing the dose of Atorvastain in achieving LDL ('bad cholesterol') and other cholesterol level goals in high risk patients who have been treated for at least the last three months with atorvastatin 40 mg and still have uncontrolled cholesterol levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35833 0
Address 35833 0
Country 35833 0
Phone 35833 0
Fax 35833 0
Email 35833 0
Contact person for public queries
Name 10458 0
Ms Louise Shiel - Project Manager
Address 10458 0
Monash University Clinical Trials Centre
Ground Floor Fethers Block
Caulfield General Medical Centre
260 Kooyong Road
CAULFIELD VIC 3162
Country 10458 0
Australia
Phone 10458 0
+61 3 9276 6166
Fax 10458 0
+61 3 9276 6249
Email 10458 0
[email protected]
Contact person for scientific queries
Name 1386 0
Associate Professor Chris Reid - Co Principal Investigator
Address 1386 0
Monash University Clinical Trials Centre
Ground Floor Fethers Block
Department of Epidemiology and Preventive Medicine - CCRE in Therapeutics
Monash University
Level 3 Burnet Bldg
89 Commercial Road
MELBOURNE VIC 3004
Country 1386 0
Australia
Phone 1386 0
+61 3 9903 0752
Fax 1386 0
Email 1386 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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