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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03469349
• Date of registration: 13/03/2018
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB APOLLO
• Scientific title: A Randomized, International, Multicenter, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Subjects With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
• Date of first enrolment: May 1, 2018
• Target sample size: 366
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03469349
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Belarus, Georgia, Kazakhstan, Russian Federation, Ukraine

Contacts

• Name: Medical Director Clinical Science
• Affiliation: Takeda

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Diseases

Intervention(s)

Drug: Actovegin

Drug: Placebo

Primary Outcome(s)

Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 [Time Frame: Baseline up to Week 12]

Secondary Outcome(s)

Percentage of Participants With Revascularization Procedures at Week 24 [Time Frame: Week 24]

Percent Change From Baseline in ICD at Weeks 2 and 24 [Time Frame: Baseline up to Weeks 2 and 24]

Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 [Time Frame: Baseline, Weeks 2, 12 and 24]

Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24 [Time Frame: Baseline, Weeks 12 and 24]

Percentage of Participants With Rest Pain at Weeks 12 and 24 [Time Frame: Weeks 12 and 24]

Secondary ID(s)

U1111-1201-7990

Actovegin-3001

2017-004741-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03469349