Peripheral arterial disease
Conditions
Interventions
Product Name: DG-041 hard gelatin capsules
Pharmaceutical Form: Capsule, hard
Current Sponsor code: DG-041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Phar
Sponsors
deCODE genetics ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ;Secondary Objective: 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. ;Primary end point(s): | — |
Countries
Iceland
Outcome results
None listed