Simvastatin (20 mg) vs ezetimibe (10 mg) plus simvastatin (20 mg) in subjects with hypercholesterolaemia and coronary heart disease (CHD)
| ISRCTN | ISRCTN47214063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47214063 |
| Protocol serial number | P03435 |
| Sponsor | Schering-Plough UK Ltd |
| Funder | Schering-Plough UK Ltd |
- Submission date
- 06/07/2004
- Registration date
- 13/08/2004
- Last edited
- 25/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
| 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 simvastatin (20 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 | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2005 |
Eligibility
| 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 years 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 | 01/04/2000 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Schering-Plough Ltd
Welwyn Garden City
AL7 1TW
United Kingdom
AL7 1TW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
