Peripheral Arterial DiseasesPhase 3APOLLONCT03469349
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
A Phase 3 study testing Actovegin in people with Peripheral Arterial Diseases, run by Takeda at 20 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Peripheral Arterial Diseases
- What is being tested?
- Actovegin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 1 May 2018to 28 Aug 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Russia16 sites
NSHI Road clinical hospital at Chelyabinsk station of OAO RZD
Chelyabinsk, 454092
Federal state budgetary research institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, 650002
BMH Kursk regional clinical hospital of Healthcare department of Kursk region
Kursk, 305007
SBHI of Moscow city "City clinical hospital #29 n.a. N.E. Bauman of Moscow Healthcare department
Moscow, 111020
SBHI of Moscow healthcare department City clinical hospital #15 n.a. O.M Filatov of Moscow healthcare department
Moscow, 111539
SBHI of Moscow Research Institute of Emergency Medicine n.a. N.V. Sklifosofsky of Moscow Healthcare department
Moscow, 129090
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
BHI of Omsk region Regional clinical hospital, vessel surgery department
Omsk, 644111
FSBEI HE Rostov State Medical University of MoH of Russia
Rostov-on-Don, 344022
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
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, 191015
SPb SBHI City multipurpose hospital #2
Saint Petersburg, 194354
Pavlov First Saint Petersburg State Medical University, Faculty surgery chair, cardio-vessel surgery department
Saint Petersburg, 197022
SPb SBHI Consulting and diagnostic center #85
Saint Petersburg, 198260
State Healthcare Institution of Saratov region "Region clinical hospitai"
Saratov, 410053
Municipal State Budgetary Healthcare Institution of Sochi "City hospital 4"
Sochi, 354057
Georgia2 sites
Center of Vascular and Heart Disease
Tbilisi, 0159
Aversi Clinic
Tbilisi, 0160
Kazakhstan2 sites
"National scientific centre of oncology and transplantology"
Astana, Z05K4F3
Regional Clinic Hospital
Shymkent, X09E1G4
About this study
Official 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
The purpose of the study is to evaluate the efficacy and safety of actovegin in participants with peripheral arterial disease (PAD) Fontaine Stage IIB.
Read the 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:
- Actovegin
- 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
- Being tested
- Actovegin, Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActoveginDrug
Actovegin intravenous infusion and tablets.
PlaceboDrug
Actovegin placebo-matching intravenous infusion and tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 12
Secondary outcomes (5)
Percent Change From Baseline in ICD at Weeks 2 and 24
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 km/h with a 10% grade.
Measured: Baseline up to Weeks 2 and 24
Absolute Change From Baseline in Absolute Claudication Distance (ACD) at 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.
Measured: Baseline, Weeks 2, 12 and 24
Percentage of Participants With Rest Pain at 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.
Measured: Weeks 12 and 24
Percentage of Participants With Revascularization Procedures at 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.
Measured: Week 24
Change From Baseline in 36-Item Short Form Survey (SF-36) at 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 quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental health score was generated which ranges between 0 and 100, with higher scores indicating a better quality of life.
Measured: Baseline, Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 May 2018
- Primary completion28 May 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseasesStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469349
- Sponsor's protocol ID
- Actovegin-3001
- Other IDs
- 2017-004741-24, U1111-1201-7990, 2017
- Acronym
- APOLLO
- Status last verified
- Oct 2020
- First submitted
- 13 Mar 2018
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03469349
- Acronym / sponsor ID
- APOLLO / Actovegin-3001
- Conditions
- Peripheral Arterial Diseases
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 28 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Actovegin
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actovegin 1200 mg | Experimental | Drug: ActoveginActovegin 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. |
| Placebo | Placebo comparator | Drug: PlaceboActovegin placebo-matching, intravenously, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActoveginActovegin intravenous infusion and tablets. | Drug | Actovegin 1200 mg |
| PlaceboActovegin placebo-matching intravenous infusion and tablets. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12
Time frame: 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.
5 secondary outcomes
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
Percentage of Participants With Rest Pain at Weeks 12 and 24
Time frame: Weeks 12 and 24
Percentage of Participants With Revascularization Procedures at Week 24
Time frame: Week 24
Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Actovegin in people with Peripheral Arterial Diseases, run by Takeda at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Russia, Georgia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 (time frame: Baseline up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.