Status:
COMPLETED
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
Lead Sponsor:
Takeda
Conditions:
Peripheral Arterial Diseases
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
The study will enroll approximately 366 participants. Participants will be randomly assigned to one of the two treatment groups in 1:1 ratio: 1. Actovegin 2. Placebo (dummy inactive substance) - this...
Eligibility Criteria
Inclusion
- Has a history of stable intermittent claudication lasting more than 6 months before Screening.
- 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.
- Has a resting Doppler ankle-brachial index of less than or equal to (\<=) 0.9.
- Has intermittent claudication with initial claudication distance (ICD) less than (\<) 200 meters.
- Is not newly diagnosed with PAD and has a history of stable PAD therapy for at least 2 weeks before Screening.
Exclusion
- Has PAD Fontaine Stage III or IV (pain at rest, non-healing ulceration, or gangrene).
- Has evidence of nonatherosclerotic PAD.
- Has greater than (\>) 25 percent (%) variability in absolute claudication distance (ACD) based on treadmill testing during the screening period.
- Has lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within 3 months before Screening.
- Is eligible for surgical/interventional reconstruction.
- Had a myocardial infarction or major cardiac surgery within 3 months before Screening.
- Has congestive heart failure (New York Heart Association Class III/IV).
- Has uncontrolled diabetes mellitus (glycosylated hemoglobin \[HbA1c \>9%\]) or diabetic polyneuropathy.
- 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).
- The subject has received any prohibited medication within 14 days before Randomization (Day 1)
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2019
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT03469349
Start Date
May 1 2018
End Date
August 28 2019
Last Update
October 28 2020
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Center of Vascular and Heart Disease
Tbilisi, Georgia, 0159
2
Aversi Clinic
Tbilisi, Georgia, 0160
3
"National scientific centre of oncology and transplantology"
Astana, Kazakhstan, Z05K4F3
4
Regional Clinic Hospital
Shymkent, Kazakhstan, X09E1G4