Recruitment

Recruitment Status
Terminated
Estimated Enrollment
114

Inclusion Criteria

Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
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
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.
Signed informed consent before any trial related activities.

Exclusion Criteria

Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
Subjects with high risk of bleeding:
Subjects with known or suspected allergy or resistant to aspirin.
...
Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
Subjects with high risk of bleeding:
Subjects with known or suspected allergy or resistant to aspirin.
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.
Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
Impaired liver function: serum ALT > 2.5 times upper limit of normal.
Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
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.
Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.

Summary

Conditions
  • Diabetes
  • Peripheral Arterial Disease
Type
Interventional
Phase
Phase 2 & Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 65 years
Gender
Both males and females

Description

Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks. Diabetic subjects who have been being under therapy w...

Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks. Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication. Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy.

Inclusion Criteria

Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
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
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.
Signed informed consent before any trial related activities.

Exclusion Criteria

Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
Subjects with high risk of bleeding:
Subjects with known or suspected allergy or resistant to aspirin.
...
Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
Subjects with high risk of bleeding:
Subjects with known or suspected allergy or resistant to aspirin.
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.
Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
Impaired liver function: serum ALT > 2.5 times upper limit of normal.
Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
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.
Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.

Locations

Denpasar, Bali
Denpasar, Bali
Denpasar, Bali
Denpasar, Bali

Tracking Information

NCT #
NCT02145988
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ketut Suastika, Prof, SpPD, MD Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital
  • Ketut Suastika, Prof, SpPD, MD Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital