Atorvastatin (10 mg) vs ezetimibe (10 mg) plus atorvastatin (10 mg) in hypercholesterolaemia and coronary heart disease (CHD)
ISRCTN | ISRCTN18808154 |
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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
Scientific
Schering-Plough Ltd
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | atorvastatin, ezetimibe |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2004 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Schering-Plough Ltd
Welwyn Garden City
AL7 1TW
United Kingdom
AL7 1TW
United Kingdom
Sponsor information
Schering-Plough UK Ltd
Industry
Industry
Schering-Plough House
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Website | http://www.sgp.com/schering_plough/index.jsp |
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https://ror.org/00148fb49 |
Funders
Funder type
Industry
Schering-Plough Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/04/2007 | Yes | No |