Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/07/2004
Date assigned
13/08/2004
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paul Quartey

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P03434

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

atorvastatin, ezetimibe

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Schering-Plough UK Ltd

Sponsor details

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

Sponsor type

Industry

Website

http://www.sgp.com/schering_plough/index.jsp

Funders

Funder type

Industry

Funder name

Schering-Plough Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17407633

Publication citations

  1. Results

    Blagden MD, Chipperfield R, Efficacy and safety of ezetimibe co-administered with atorvastatin in untreated patients with primary hypercholesterolaemia and coronary heart disease., Curr Med Res Opin, 2007, 23, 4, 767-775, doi: 10.1185/030079907X182059.

Additional files

Editorial Notes