NCT03469349 (APOLLO) is a Phase 3 clinical trial of Actovegin in Peripheral Arterial Diseases, sponsored by Takeda.

Who is sponsoring NCT03469349?

NCT03469349 is sponsored by Takeda.

What drugs are being tested in NCT03469349?

Interventions in NCT03469349: Actovegin, Placebo.

What condition does NCT03469349 study?

NCT03469349 studies Peripheral Arterial Diseases.

Is NCT03469349 still recruiting?

NCT03469349 is currently completed. Last updated 28 October 2020.

Are results published for NCT03469349?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-28 · How we verify

NCT03469349: APOLLO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 28 October 2020

What this trial tests

Phase 3 trial testing Actovegin in Peripheral Arterial Diseases in 366 participants. Completed in 28 August 2019.

Timeline

1 May 2018

Primary endpoint
28 May 2019

28 August 2019

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	366
Start date	1 May 2018
Primary completion	28 May 2019
Estimated completion	28 August 2019
Sites	20 locations across Georgia, Russia, Kazakhstan

Drugs / interventions tested

Actovegin — full drug profile →
Placebo

Conditions studied

Peripheral Arterial Diseases — all drugs for Peripheral Arterial Diseases →

Sponsor

Takeda — full company profile →

Who can join

Adults 40 to 75, any sex, with Peripheral Arterial Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 Primary · Baseline up to 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.

Group	Value	95% CI
Placebo	21.99	± 9.286
Actovegin 1200 mg	51.17	± 9.187

Percent Change From Baseline in ICD at Weeks 2 and 24 Secondary · Baseline up to Weeks 2 and 24

Week 2

Group	Value	95% CI
Placebo	6.58	± 8.131
Actovegin 1200 mg	22.45	± 7.981

Week 24

Group	Value	95% CI
Placebo	25.12	± 10.665
Actovegin 1200 mg	60.63	± 10.614

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

ACD was the distance at which claudication pain becomes so severe that the participant was forced to stop, also known as maximal walking distance. ACD was assessed using treadmill testing. A fixed load treadmill test was carried out at 3.0 km/h with a 10% grade. The investigator will record the distance from walking start to the point where the participant is unable to walk anymore.

Baseline

Group	Value	95% CI
Placebo	134.5	± 58.84
Actovegin 1200 mg	137.1	± 72.76

Change at Week 2

Group	Value	95% CI
Placebo	17.61	± 30.781
Actovegin 1200 mg	46.28	± 179.356

Change at Week 12

Group	Value	95% CI
Placebo	30.05	± 50.530
Actovegin 1200 mg	75.51	± 190.808

Change at Week 24

Group	Value	95% CI
Placebo	36.37	± 71.834
Actovegin 1200 mg	86.47	± 227.491

Percentage of Participants With Rest Pain at Weeks 12 and 24 Secondary · Weeks 12 and 24

Rest pain was defined as a continuous burning pain, that begins, or is aggravated, after reclining or elevating the limb and is relieved by sitting or standing.

Week 12

Group	Value	95% CI
Placebo	0
Actovegin 1200 mg	0.6

Week 24

Group	Value	95% CI
Placebo	1.1
Actovegin 1200 mg	0.6

Percentage of Participants With Revascularization Procedures at Week 24 Secondary · Week 24

Revascularization was defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores were used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.

Group	Value	95% CI
Placebo	0.0
Actovegin 1200 mg	1.1

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

The SF-36 was a questionnaire that evaluated a participant's health related quality of life. SF-36 included 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical health score was generated which ranges between 0 and 100, with higher scores indicating a better

Physical Health Score: Baseline

Group	Value	95% CI
Placebo	39.533	± 6.3023
Actovegin 1200 mg	39.905	± 6.5138

Physical Health Score: Change at Week 12

Group	Value	95% CI
Placebo	2.029	± 5.1633
Actovegin 1200 mg	2.368	± 5.3725

Physical Health Score: Change at Week 24

Group	Value	95% CI
Placebo	1.752	± 6.1229
Actovegin 1200 mg	2.333	± 5.1950

Mental Health Score: Baseline

Group	Value	95% CI
Placebo	47.961	± 9.4891
Actovegin 1200 mg	47.531	± 9.8667

Mental Health Score: Change at Week 12

Group	Value	95% CI
Placebo	1.134	± 7.2459
Actovegin 1200 mg	2.434	± 8.2234

Mental Health Score: Change at Week 24

Group	Value	95% CI
Placebo	0.571	± 8.6698
Actovegin 1200 mg	3.063	± 9.0286

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug up to Day 168. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 3/182 (2%)

Deaths: 0/182

Actovegin 1200 mg

Serious: 9/184 (5%)

Deaths: 0/184

Serious adverse events (11 terms)

Reaction	System	Placebo	Actovegin 1200 mg
Gangrene	Infections and infestations	—	—
Angina unstable	Cardiac disorders	—	—
Pneumonia	Infections and infestations	—	—
Arterial bypass thrombosis	Injury, poisoning and procedural complications	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—
Haemorrhagic stroke	Nervous system disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Peripheral artery occlusion	Vascular disorders	—	—
Thrombophlebitis	Vascular disorders	—	—
Extremity necrosis	Vascular disorders	—	—
Thrombophlebitis superficial	Vascular disorders	—	—

Other adverse events (33 terms — click to expand)

Reaction	System	Placebo	Actovegin 1200 mg
Nasopharyngitis	Infections and infestations	—	—
Respiratory tract infection	Infections and infestations	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Carbohydrate metabolism disorder	Congenital, familial and genetic disorders	—	—
Pain	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Pyelonephritis chronic	Infections and infestations	—	—
Acute sinusitis	Infections and infestations	—	—
Anal abscess	Infections and infestations	—	—
Chronic hepatitis C	Infections and infestations	—	—
Cystitis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Paronychia	Infections and infestations	—	—
Respiratory tract infection viral	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Ear injury	Injury, poisoning and procedural complications	—	—
Shunt thrombosis	Injury, poisoning and procedural complications	—	—
Wound	Injury, poisoning and procedural complications	—	—
Blood creatinine increased	Investigations	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Osteochondrosis	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Cerebral arteriosclerosis	Nervous system disorders	—	—
Insomnia	Psychiatric disorders	—	—
Leukocyturia	Renal and urinary disorders	—	—
Proteinuria	Renal and urinary disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—
Skin ulcer	Skin and subcutaneous tissue disorders	—	—
Hypertension	Vascular disorders	—	—
Peripheral arterial occlusive disease	Vascular disorders	—	—

Most-reported serious reactions: Gangrene, Angina unstable, Pneumonia, Arterial bypass thrombosis, Hip fracture, Haemorrhagic stroke, Pulmonary embolism, Peripheral artery occlusion.

Data from ClinicalTrials.gov NCT03469349 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

PRISMA Systematic Literature Review, including with Meta-Analysis vs. Chatbot/GPT (AI) regarding Current Scientific Data on the Main Effects of the Calf Blood Deproteinized Hemoderivative Medicine (Actovegin) in Ischemic Stroke.
Anghelescu A, Firan FC, Onose G, Munteanu C, et al · · 2023 · cited 14× · PMID 37371718 · DOI 10.3390/biomedicines11061623

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03469349 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 28 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03469349.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing