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

ISRCTN ISRCTN18808154
DOI https://doi.org/10.1186/ISRCTN18808154
Secondary identifying numbers P03434
Submission date
06/07/2004
Registration date
13/08/2004
Last edited
15/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Quartey
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHypercholesterolaemia and CHD
InterventionDouble-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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)atorvastatin, ezetimibe
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2004
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaMale or female subjects aged 18-75 with screening low-density lipoprotein cholesterol (LDL-C) between 3.3 and 4.9 mmol/L
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2004
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Schering-Plough UK Ltd
Industry

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

Website http://www.sgp.com/schering_plough/index.jsp
ROR logo "ROR" https://ror.org/00148fb49

Funders

Funder type

Industry

Schering-Plough Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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