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

NCT03469349 | Completed Phase 3 Results

• 3 other identifiers: Actovegin-30012017-004741-24U1111-1201-7990
• Study Type: interventional
• Target: 366
• Locations: 3 countries
• Sites: 20

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.

Conditions

Peripheral Arterial Diseases

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12

  ICD was the distance walked at the onset of claudication pain or pain-free walking distance. ICD was assessed using treadmill testing. A fixed load treadmill test was carried out at 3.0 kilometer per hour (km/h) with a 10 percent (%) grade.

  Baseline up to Week 12

Secondary Outcomes (5)

• Percent Change From Baseline in ICD at Weeks 2 and 24

  Baseline up to Weeks 2 and 24

• Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24

  Baseline, Weeks 2, 12 and 24

• Percentage of Participants With Rest Pain at Weeks 12 and 24

  Weeks 12 and 24

• Percentage of Participants With Revascularization Procedures at Week 24

  Week 24

• Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24

  Baseline, Weeks 12 and 24

Study Arms (2)

Actovegin 1200 mg

EXPERIMENTAL

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.

Drug: Actovegin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Actovegin DRUG

Actovegin intravenous infusion and tablets.

Actovegin 1200 mg

Placebo DRUG

Actovegin placebo-matching intravenous infusion and tablets.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (20)

Center of Vascular and Heart Disease

Tbilisi, 0159, Georgia

Location

Aversi Clinic

Tbilisi, 0160, Georgia

Location

"National scientific centre of oncology and transplantology"

Astana, Z05K4F3, Kazakhstan

Location

Regional Clinic Hospital

Shymkent, X09E1G4, Kazakhstan

Location

NSHI Road clinical hospital at Chelyabinsk station of OAO RZD

Chelyabinsk, 454092, Russia

Location

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

Kemerovo, 650002, Russia

Location

BMH Kursk regional clinical hospital of Healthcare department of Kursk region

Kursk, 305007, Russia

Location

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

Moscow, 111020, Russia

Location

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

Moscow, 111539, Russia

Location

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

Moscow, 129090, Russia

Location

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, 630117, Russia

Location

BHI of Omsk region Regional clinical hospital, vessel surgery department

Omsk, 644111, Russia

Location

FSBEI HE Rostov State Medical University of MoH of Russia

Rostov-on-Don, 344022, Russia

Location

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, 390026, Russia

Location

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

Saint Petersburg, 191015, Russia

Location

SPb SBHI City multipurpose hospital #2

Saint Petersburg, 194354, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

SPb SBHI Consulting and diagnostic center #85

Saint Petersburg, 198260, Russia

Location

State Healthcare Institution of Saratov region "Region clinical hospitai"

Saratov, 410053, Russia

Location

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

Sochi, 354057, Russia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Actovegin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: May 1, 2018
• Primary Completion: May 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

GE (2); KA (2); RU (16)