DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

Inclusion Criteria:

• Signed informed consent before any trial related activities.

• Male or female subjects of 40 - 65 years of age.

• Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.

• Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive

Exclusion Criteria:

• Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.

• Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.

• Impaired liver function: serum ALT > 2.5 times upper limit of normal.

• Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.

• Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.

• Subjects with concurrent herbal (alternative) medicines or food supplements

• Subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.

• Subjects with high risk of bleeding:

• Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.

• Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.

• Subjects with known or suspected allergy or resistant to aspirin.