E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
1. Patients diagnosed as having a stroke based on the WHO Criteria Patients with transient ischaemic attacks will be included if symptoms of motor or sensory loss were demonstrable with full recovery within 24 hours. Only strokes and TIA that are ischaemic in nature (thrombo-embolic) will be included in the study |
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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 |
Compare the safety and efficacy of the co-admistration of niaspan with statndard lipid lowering therapy (simvastatin) vs. simvastatin with placebo amongst South Asian stroke survivors (280 in total). Efficacy is determined by changes in carotid intima thickness at 12 and 24 months following randomisation. |
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E.2.2 | Secondary objectives of the trial |
Determine the effects of co-admistration of niaspan with statndard lipid lowering therapy (simvastatin) vs. simvastatin with placebo on 1. Quality of life measures 2. inflammatory markers of atherosclerosis 3. dyslpidaemia associated with stroke |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subjects demonstrating their willingness to participate in the study and comply with its procedures by signing a written informed consent. 2. Subjects must be more than 18 yrs of age. 3. Subjects must have an LDL cholesterol level <5.2 mmol/l at visit 1 and <2.5 mmol/l at visit 3 (baseline) 4. Subjects must have a documented history of stroke or TIA that is ischaemic in nature. This is to be supported by a report of computed tomography (CT) scanning (taken 72 hours of the ictus). And it is at least 3 months since the cerebrovascular event. 5. Subjects that are of South Asian origin (3 of 4 grandparents must originate from the Indian subcontinent). 6. Subjects must have a stable weight history (visit 2-3), prior to entry for randomisation.
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E.4 | Principal exclusion criteria |
1. Subjects whose liver transaminases (ALT, AST) are 1 ½ times the upper limit of normal or active liver disease at visit 1. 1. Subjects with evidence of current myopathy (including subjects with CK > 1 ½ times above the upper limit of normal at visit 3 (baseline). 2. Subjects with clinical laboratory tests (blood chemistries and urine analysis) outside the normal range that are clinically unacceptable to study physicians (EAH, KS, HSL, GYHL) during visits 1-3. 3. Subjects that are type 2 diabetic that have had a change in anti-diabetic therapy within 3 months of visit 1. 4. Subjects who have known hypersensitivity to either Simvastatin or Niaspan. 5. Any condition or situation, which, in the opinion of the lead study investigator (EAH), might pose a risk to the subject or interfere with the participation in the study (including hypothyroidism, severe cardiovascular disease (events within 3 months of visit 1)). 6. Female subjects who are pregnant, breast feeding or of childbearing potential, who are not using a suitable method of birth control. 7. Subjects who have not observed the designated washout periods for any of the prohibited medications outlined in section 6.1. 8. Uncontrolled hypertension (treated or untreated) at visit 3: systolic blood pressure >160mmHg or diastolic blood pressure >100mgHg.
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E.5 End points |
E.5.1 | Primary end point(s) |
• To compare the efficacy of co-administration of Niaspan (1000-2000mg) with Simvastatin (10-40mg) versus placebo with Simvastatin (10-40mg) in carotid artery IMT regression after 12 and 24 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |