Phase 3
Completed N=366
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
Peripheral Arterial Diseases
Source: ClinicalTrials.gov NCT03469349 ↗
Enrolled (actual)
366
Serious AEs
3.3%
Results posted
Oct 2020
Primary outcomePrimary: Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 — 21.99; 51.17 percent change — p=0.0041
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Initial Claudication Distance (ICD) at Week 12 |
21.99; 51.17 | 0.0041 sig |
| SECONDARY Percent Change From Baseline in ICD at Weeks 2 and 24 |
6.58; 22.45; 25.12; 60.63 | 0.0431 sig |
| SECONDARY Absolute Change From Baseline in Absolute Claudication Distance (ACD) at Weeks 2, 12 and 24 |
134.5; 137.1; 17.61; 46.28; 30.05; 75.51 | 0.0227 sig |
| SECONDARY Percentage of Participants With Rest Pain at Weeks 12 and 24 |
0; 0.6; 1.1; 0.6 | 0.9592 |
| SECONDARY Percentage of Participants With Revascularization Procedures at Week 24 |
0.0; 1.1 | 0.9424 |
| SECONDARY Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24 |
39.533; 39.905; 2.029; 2.368; 1.752; 2.333 | 0.3758 |
Eligibility Criteria
Inclusion Criteria
- 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 ( ) 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.
Data sourced from ClinicalTrials.gov (NCT03469349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.