E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007648 |
E.1.2 | Term | Cardiovascular disease, unspecified |
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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 |
The primary aim of the trial is to evaluate whether a “polypill” a fixed low dose combination of blood pressure lowering drugs (an ACE inhibitor and diurectic), cholesterol lowering drugs (a statin) and asprin results in improved systolic Blood Pressue and LDL-cholesterol(bad cholesterol) levels and is tolerable compared with placebo (a tablet containing no medication) in individuals at raised risk of 7.5% or more in the next 5 years of a major cardiovascular event, such as a heart attack or stroke. (This estimate is made by considering a number of factors including your age, gender, blood pressure, cholesterol level and whether you smoke). |
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E.2.2 | Secondary objectives of the trial |
Secondary aims are to measure adherence, change in diastolic BP, total, HDL(good cholesterol) and non-HDL cholesterol, triglycerides, frequency of switching to open-label treatment, change in cardiovascular disease risk and adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The trial targets individuals who have an absolute risk of a major cardiovascular event in next 5 years of at least 7.5% but who do not meet current guidelines for treatment with aspirin, or BP-lowering or cholesterol-lowering medications. Individuals are eligible for inclusion if all of the following criteria are satisfied: • Adults (> 18 years) with a CVD risk over 5 years of at least 7.5%, determined by the Framingham risk function using data on age, gender, BP, total cholesterol, HDL cholesterol and cigarette smoking status. The Framingham risk function will be recalibrated for each country using local incidence data from the WHO Global Burden of Disease Project. Those with an estimated 5 year risk of 5.0 – <7.5% risk would also be eligible with two additional risk factors of: o Body mass index >30 kg/m2, waist circumference >102 cm in men or >88 cm in women o Heart rate >80 beats/min o Fasting glucose 5.6 - <7.0 mmol/L o Triglycerides >1.7 mmol/l o Family history of premature coronary heart disease or ischaemic stroke in a first degree male relative before the age of 55 years or a first degree female relative before the age of 65 years o Glomerular filtration rate (GFR) <60 ml/min • No indication or contraindication for use of low-dose aspirin, ACE inhibitor, low-dose diuretic or statin. • The participant is able to give informed consent.
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E.4 | Principal exclusion criteria |
Individuals will NOT be eligible if there is one or more of the following: • Clear indication for antiplatelet, BP lowering or cholesterol lowering medications. This includes: current treatment with BP or cholesterol lowering medicines, diabetes mellitus, existing CVD, or individuals with LDL cholesterol, systolic BP or estimated CVD risk values above those recommended for treatment by local guidelines. • Contraindication to any of the components of the polypill. • Life-limiting disease or events
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study outcomes are change in systolic blood pressure, change in LDL-cholesterol, adherence (self-reported and pill counts) and tolerability (the proportion who withdraw from study treatment). Secondary outcomes are change in diastolic blood pressure, total cholesterol and non-HDL cholesterol, frequency of switching to open-label treatment, change in CVD risk and adverse events. |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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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The trial ends when the treatment period is concluded at the last visit (end of week 12) for each subject. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |