E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermittent claudication |
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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 |
To assess whether in patients with mild to moderate intermittent claudication who are amenable to supervised exercise (SEx) and suitable for cilostazol therapy, treatment by: 1. Best medical therapy (BMT) alone 2. BMT + SEx 3. BMT + Cilostazol 4. BMT + SEx + Cilostazol is assocaited with improvement in pain free and absolute walking distance and cost-effective utilisation of NHS resources |
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E.2.2 | Secondary objectives of the trial |
Patients selected to receive cilostazol therapy will be prescribed cilostazol for a 12 month period after which medication will be withdrawn to investigate the effects of drug withdrawl on pain free and absolute walking distance. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Intermittent claudication as the exercise limiting diagnosis 2. A maximum walking distance of 20-500m (as measured by Treadmill Walking Test) 3. Patient must not have inflow disease requiring intervention 4. Patient must not have any other medical condition that may prevent participation in exercise classes 5. Patient suitable for treatment with cilostazol 6. Patient capable and willing to give fully informed consent |
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E.4 | Principal exclusion criteria |
1. Exercise limited by condition other than intermittent claudication 2. Supra-inguinal arterial disease requiring intervention 3. Presence of other medical condition that may prevent participation in exercise classes 4. Patient having suffered an MI, TIA, CVA or PTCA within 3 months prior to recruitment 5. Patient unsuitable for treatment with cilostazol. Cilostazol treatment is contraindicated in patients: with creatinine clearance rate <25 ml/min with congestive heart failure taking CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, erythromycin, ketoconazole, lansoprazole, omeprazole and HIV-1 protease inhibitors)
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in absolute walking distance Improvement in pain free walking distance Ankle-brachial pressure index Generic and disease-specific health related quality of life Cost-effective utilisation of NHS resources Cardiovascular and all-cause morbidity and mortality |
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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 | No |
E.6.4 | Safety | No |
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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Supervised exercise programme |
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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.8.5 | 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 | 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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |