Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
Condition: Peripheral Arterial Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Intervention: Actovegin; Placebo
Intervention description: Actovegin intravenous infusion and tablets.; Actovegin placebo-matching intravenous infusion and tablets.
Intervention MeSH terms: Actovegin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of the study is to evaluate the efficacy and safety of actovegin in participants
      with peripheral arterial disease (PAD) Fontaine Stage IIB.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a history of stable intermittent claudication lasting more than 6 months before
             Screening.

          2. Has a diagnosis of peripheral arterial disease (PAD) (Code I70.2 according to the
             international classification of diseases-10th revision) Fontaine Stage IIB confirmed
             by ultrasound color duplex imaging.

          3. Has a resting Doppler ankle-brachial index of less than or equal to (<=) 0.9.

          4. Has intermittent claudication with initial claudication distance (ICD) less than (<)
             200 meters.

          5. Is not newly diagnosed with PAD and has a history of stable PAD therapy for at least 2
             weeks before Screening.

        Exclusion Criteria:

          1. Has PAD Fontaine Stage III or IV (pain at rest, non-healing ulceration, or gangrene).

          2. Has evidence of nonatherosclerotic PAD.

          3. Has greater than (>) 25 percent (%) variability in absolute claudication distance
             (ACD) based on treadmill testing during the screening period.

          4. Has lower extremity arterial reconstruction (surgical or endovascular) or
             sympathectomy within 3 months before Screening.

          5. Is eligible for surgical/interventional reconstruction.

          6. Had a myocardial infarction or major cardiac surgery within 3 months before Screening.

          7. Has congestive heart failure (New York Heart Association Class III/IV).

          8. Has uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c >9%]) or diabetic
             polyneuropathy.

          9. Has any other illness that significantly limits exercise capacity or other medical
             condition, including any psychiatric disorder that limits participation (in the
             judgement of the investigator).

         10. The subject has received any prohibited medication within 14 days before Randomization
             (Day 1)

         11. The subject is undergoing the supervised exercise training program by the time of
             Screening and is going to continue this program due to its effectiveness.