E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects who in the opinion of the GP investigator would require a statin for primary prevention according to the 2008 NICE guideline on lipid modification: adults over 40 who have a 20% or greater 10-risk of developing cardiovascular disease. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Double-blinded placebo-controlled randomised clinical trials (RCTs) have made major contributions to medical research. But they are associated with three major issues. Firstly, the costs of conducting these studies can often be prohibitive. Secondly, the data are often collected de novo with study-specific case report forms rather than using existing clinical records. But a considerable amount of the data needed in RCTs is increasingly collected as part of routine health care. Thirdly, RCTs now often recruit participants who are not representative of patients who subsequently receive treatment in the real world clinical practice. A major opportunity in extending research opportunities and improving the public health value of RCTs could be by randomising patients at the point of care with data collection and follow up conducted by using the routinely collected health care records. This is also known as RCTs within the database. With this design, the research costs are reduced and length |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to measure laboratory and clinical outcomes and compare these outcomes between the two randomly allocated statins. The trial is large enough to show differences in laboratory measures of lipid levels (HDL and LDL). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Study inclusion criteria
(i) Age 40 or over (ii) Able and willing to provide informed consent to study participation (iii) Fully registered with the general practice for at least 6 months (i.e. subjects who are newly registered with the practice will not be eligible) (iv) Subjects who had not been prescribed a statin previously (v) Subjects who in the opinion of the GP Investigator should be prescribed a statin (vi) Subjects who in the opinion of the GP Investigator have primary hypercholesterolaemia (cholesterol of 5.0 mmol/l or above) and have not responded adequately to diet or other appropriate measures (i.e. one of licensed indications of statins) (vii) Subjects who in the opinion of the GP Investigator would require a statin for primary prevention according to the 2008 NICE guideline on lipid modification: adults over 40 who have a 20% or greater 10-year risk of developing cardiovascular disease, based on Framingham 1991 10-year risk equations and clinical judgement
Further details can be found in the British National Formulary (section 2.12) and in the 2008 NICE guideline on lipid modification [5], which will be available on the study website.
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E.4 | Principal exclusion criteria |
Study exclusion criteria
Statins are contra-indicated in active liver disease (or persistently abnormal liver function tests), in pregnancy (adequate contraception required during treatment and for 1 months afterwards) and breast-feeding. Further details can be found in the British National Formulary (section 2.12)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to evaluate the feasibility of conducting randomised clinical trials within the database. The evaluation of the methodological endpoint (i.e., the feasibility of the trial) will consist of a descriptive analysis of the recruitment rate and characteristics of the study population compared to other patients in GPRD exposed to study medication. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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3-month after start of study (provision of two blood samples) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |