E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peripheral arterial 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 |
The main objectives:
1. To assess the pharmacodynamic response of two different doses of DG-041 (100 mg b.i.d. and 400 mg b.i.d.) compared to placebo. The following parameters will be examined: a. Platelet aggregation. b. Platelet function (PFA-100 test). c. Serum or plasma biomarkers, including but not limited to: high-sensitivity C-reactive protein (hs-CRP), soluble P-selectin (sP-selectin), soluble CD40 ligand (sCD40L), vascular cell adhesion molecule (VCAM), intracellular adhesion molecule (ICAM) and monocyte chemotactic protein-1 (MCP-1). d. Urinary 11-dehydro-thromboxane B2 (11-dehydroTxB2) or other urinary biomarkers of interest. 2. To evaluate the safety profile of DG-041 during multiple dose administration in patients with peripheral artery disease (PAD).
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E.2.2 | Secondary objectives of the trial |
The secondary objectives: 1. To estimate drug effect on ankle/brachial index (ABI) measurements. 2. To examine whether there is a difference between genotype positive and genotype negative patients with regard to pharmacodynamic (PD) measurements and/or ABI. 3. To characterize DG-041 pharmacokinetics (PK) in patients with PAD (in a subset of 60 patients). 4. To explore influence of genetic polymorphisms for cytochrome P-450 (CYP450) on DG-041 pharmacokinetics. correlate to drug metabolism of study drug.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female over the age of 40. 2. Diagnosed PAD with IC that has been stable for at least 6 months. 3. Fontaine class of IC of II-III. 4. ABI < 0.9 on at least one side. 5. Signed informed consent form. |
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E.4 | Principal exclusion criteria |
1. Women of childbearing potential (i.e. not surgically sterile or at least 2 years postmenopausal). 2. Serum creatinine above 2 × upper limit of normal (ULN). 3. Active liver disease or aspartate transaminase (AST) and alanine transaminase (ALT) above 3 × ULN. 4. Recent (i.e. within 3 months) revascularization or other surgical procedures. 5. History of myocardial infarction or stroke within 3 months prior to randomization. 6. Active treatment with other antiplatelet drugs (specifically, clopidogrel and cilostazol) for 3 months prior to enrollment (patients are allowed to take ASA [75 mg daily] or other non-steroidal anti-inflammatory drugs, lipid lowering drugs and antihypertensives). 7. Active malignant disease (excluding basal cell carcinoma). 8. Any disease or condition that in the judgment of the investigator would interfere with the patient’s ability to participate in the trial. 9. Unable or not willing to sign informed consent form.
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |