A randomized, double blind, placebo controlled phase II evaluation of the pharmacokinetics, pharmacodynamics and safety of DG-041 in PAD patients - N/A
- Conditions
- Peripheral arterial disease
- Registration Number
- EUCTR2006-001368-22-IS
- Lead Sponsor
- deCODE genetics ehf.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method