Trial · NCT03469349
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
NCT03469349, Phase 3, Completed, Takeda; results first posted 2020-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB. Trials, record NCT03469349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03469349
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
- NCT number
- NCT03469349
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 366 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Peripheral Arterial Diseases
- Interventions
- Actovegin, Placebo
- First posted
- 2018-03-19
- Last updated
- 2020-10-28
- Other registries' IDs
- eudract:2017-004741-24
- Results first posted
- 2020-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 | 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. |
| Secondary | Percent Change From Baseline in ICD at Weeks 2 and 24 | Baseline up to 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. |
| Secondary | Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | 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. |
| Secondary | Percentage of Participants With Rest Pain at Weeks 12 and 24 | 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. |
| Secondary | Percentage of Participants With Revascularization Procedures at Week 24 | 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. |
| Secondary | Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24 | 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 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 | Baseline up to Week 12 | The full analysis set (FAS) included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in ICD at Weeks 2 and 24 | Baseline up to Weeks 2 and 24 | The FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. Participants evaluable for this measure at given time point were included for the assessment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | Baseline, Weeks 2, 12 and 24 | The FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. Participants evaluable for this measure at given time point were included for the assessment. | meter | MEAN |
| SECONDARY | Percentage of Participants With Rest Pain at Weeks 12 and 24 | Weeks 12 and 24 | The FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. Participants evaluable for this measure at given time point were included for the assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Revascularization Procedures at Week 24 | Week 24 | The FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | The FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary endpoint. Participants evaluable for this measure at given time point were included for the assessment. | points on a scale | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 | Placebo | 21.99 | Standard Error 9.286 | percent change | |
| Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 | Actovegin 1200 mg | 51.17 | Standard Error 9.187 | percent change | |
| Percent Change From Baseline in ICD at Weeks 2 and 24 | Placebo | Week 2 | 6.58 | Standard Error 8.131 | percent change |
| Percent Change From Baseline in ICD at Weeks 2 and 24 | Actovegin 1200 mg | Week 2 | 22.45 | Standard Error 7.981 | percent change |
| Percent Change From Baseline in ICD at Weeks 2 and 24 | Placebo | Week 24 | 25.12 | Standard Error 10.665 | percent change |
| Percent Change From Baseline in ICD at Weeks 2 and 24 | Actovegin 1200 mg | Week 24 | 60.63 | Standard Error 10.614 | percent change |
| Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | Placebo | Baseline | 134.5 | Standard Deviation 58.84 | meter |
| Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | Actovegin 1200 mg | Baseline | 137.1 | Standard Deviation 72.76 | meter |
| Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | Placebo | Change at Week 2 | 17.61 | Standard Deviation 30.781 | meter |
| Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 | Actovegin 1200 mg | Change at Week 2 | 46.28 | Standard Deviation 179.356 | meter |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 182 | |
| Overall Study | STARTED | Actovegin 1200 mg | 184 | |
| Overall Study | COMPLETED | Placebo | 177 | |
| Overall Study | COMPLETED | Actovegin 1200 mg | 174 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Actovegin 1200 mg | 10 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 1 | 182 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Actovegin 1200 mg | 0 | 184 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 182 | |
| other | Atrial fibrillation | Cardiac disorders | Actovegin 1200 mg | 1 | 184 | |
| other | Carbohydrate metabolism disorder | Congenital, familial and genetic disorders | Placebo | 0 | 182 | |
| other | Carbohydrate metabolism disorder | Congenital, familial and genetic disorders | Actovegin 1200 mg | 1 | 184 | |
| other | Pain | General disorders | Placebo | 0 | 182 | |
| other | Pain | General disorders | Actovegin 1200 mg | 1 | 184 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 182 | |
| other | Nasopharyngitis | Infections and infestations | Actovegin 1200 mg | 5 | 184 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 182 |
| Total, all-cause mortality | Actovegin 1200 mg | 0 | 184 |
| Total, other adverse events | Placebo | 20 | 182 |
| Total, other adverse events | Actovegin 1200 mg | 23 | 184 |
| Total, serious adverse events | Placebo | 3 | 182 |
| Total, serious adverse events | Actovegin 1200 mg | 9 | 184 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Actovegin 1200 mg vs Placebo: deaths from any cause | Trial comparisons |
| Actovegin 1200 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03469349
GET https://conductscience.org/api/trials/v1/NCT03469349/results?page=2