Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB

NCT ID: NCT03469349

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-08-28

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 is a tablet/intravenous infusion that looks like the study drug but has no active ingredient

All participants will be asked to take intravenous infusion for 2 weeks followed by oral tablets for 10 weeks.

This multi-center trial will be conducted Russia, Georgia, and Kazakhstan. The overall time to participate in this study is 25 to 26 weeks. Participants will make multiple visits to the clinic, and 12 weeks after last dose of study drug for a follow-up assessment.

Conditions

Peripheral Arterial Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Actovegin 1200 mg

Actovegin 1200 milligram (mg), intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (TID) (1200 mg/day) for up to 10 weeks.

Group Type: EXPERIMENTAL

Actovegin

Intervention Type: DRUG

Actovegin intravenous infusion and tablets.

Placebo

Actovegin placebo-matching, intravenously, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Actovegin placebo-matching intravenous infusion and tablets.

Interventions

Actovegin

Actovegin intravenous infusion and tablets.

Intervention Type: DRUG

Placebo

Actovegin placebo-matching intravenous infusion and tablets.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Center of Vascular and Heart Disease

Tbilisi, , Georgia

Aversi Clinic

Tbilisi, , Georgia

"National scientific centre of oncology and transplantology"

Astana, , Kazakhstan

Regional Clinic Hospital

Shymkent, , Kazakhstan

NSHI Road clinical hospital at Chelyabinsk station of OAO RZD

Chelyabinsk, , Russia

Federal state budgetary research institution Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, , Russia

BMH Kursk regional clinical hospital of Healthcare department of Kursk region

Kursk, , Russia

SBHI of Moscow city "City clinical hospital #29 n.a. N.E. Bauman of Moscow Healthcare department

Moscow, , Russia

SBHI of Moscow healthcare department City clinical hospital #15 n.a. O.M Filatov of Moscow healthcare department

Moscow, , Russia

SBHI of Moscow Research Institute of Emergency Medicine n.a. N.V. Sklifosofsky of Moscow Healthcare department

Moscow, , Russia

Scientific Research Institute of Clinical and Experimental Lymphology - a branch of the Institute of Cytology and Genetics of the Siberian Branch of the Russian Academy of Sciences

Novosibirsk, , Russia

BHI of Omsk region Regional clinical hospital, vessel surgery department

Omsk, , Russia

FSBEI HE Rostov State Medical University of MoH of Russia

Rostov-on-Don, , Russia

SBHI of Ryazan region Regional clinical cardiological dispensary, vessel surgery department/ FSBI of Ryazan Region "Ryazan State Medical Univesity n.a. I.P. Pavlov" of MoH of Russia

Ryazan, , Russia

North-Western State Medical University named after I.I. Mechnikov

Saint Petersburg, , Russia

SPb SBHI City multipurpose hospital #2

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University, Faculty surgery chair, cardio-vessel surgery department

Saint Petersburg, , Russia

SPb SBHI Consulting and diagnostic center #85

Saint Petersburg, , Russia

State Healthcare Institution of Saratov region "Region clinical hospitai"

Saratov, , Russia

Municipal State Budgetary Healthcare Institution of Sochi "City hospital 4"

Sochi, , Russia

Countries

Georgia; Kazakhstan; Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-004741-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1201-7990

Identifier Type: OTHER

Identifier Source: secondary_id

Actovegin-3001

Identifier Type: -

Identifier Source: org_study_id