Atorvastatin (10 mg) vs ezetimibe (10 mg) plus atorvastatin (10 mg) in hypercholesterolaemia and coronary heart disease (CHD)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Paul Quartey
Scientific

Schering-Plough Ltd
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hypercholesterolaemia and CHD
Intervention	Double-blind study involving 6 weeks treatment with a once daily dose of atorvastatin (10 mg) plus either ezetimibe (10 mg) or matching ezetimibe placebo. Blood samples will be collected prior to treatment to use as a baseline and at the end of the 6 week treatment period to determine the effect of the treatments on the lipid profiles. These pre and post treatment blood samples will also be analysed for haematology and clinical chemistry parameters for safety assessment purposes. The objective of the study is to compare the post treatment lipid results (primarily LDL-C) with the baseline values between the two treatment groups. In addition, the usual safety assessments (i.e. adverse events) and details of concomitant medications etc. will be collected during the study.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	atorvastatin, ezetimibe
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Key inclusion criteria	Male or female subjects aged 18-75 with screening low-density lipoprotein cholesterol (LDL-C) between 3.3 and 4.9 mmol/L
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

Schering-Plough Ltd

Welwyn Garden City
AL7 1TW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No