Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB (APOLLO)
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|ClinicalTrials.gov Identifier: NCT03469349|
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : October 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Diseases||Drug: Actovegin Drug: Placebo||Phase 3|
The study will enroll approximately 366 participants. Participants will be randomly assigned to one of the two treatment groups in 1:1 ratio:
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||May 1, 2018|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||August 20, 2019|
Experimental: Actovegin 1200 mg
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.
Actovegin intravenous infusion and tablets.
Placebo Comparator: Placebo
Actovegin placebo-matching, intravenously, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks.
Actovegin placebo-matching intravenous infusion and tablets.
- Percent Change in Initial Claudication Distance (ICD) from Baseline to Week 12 of Study Treatment [ Time Frame: Baseline, Week 12 ]ICD will be assessed using treadmill testing. ICD is the distance walked at the onset of claudication pain or pain-free walking distance.
- Percent Change in ICD from Baseline to Weeks 2 and 24 After Randomization [ Time Frame: Baseline, Weeks 2 and 24 ]ICD will be assessed using treadmill testing. ICD is the distance walked at the onset of claudication pain or pain-free walking distance.
- Change in Absolute Claudication Distance (ACD) from Baseline to Weeks 2, 12 and 24 [ Time Frame: Baseline, Weeks 2, 12 and 24 ]ACD will be assessed using treadmill testing. ACD is the distance at which claudication pain becomes so severe that the participant is forced to stop, also known as maximal walking distance.
- Proportion of Participants With Rest Pain at Weeks 12 and 24 After Randomization [ Time Frame: Weeks 12 and 24 ]Rest pain is defined as a continuous burning pain, that begins, or is aggravated, after reclining or elevating the limb and is relieved by sitting or standing.
- Proportion of Participants with Revascularization Procedures at Week 24 After Randomization [ Time Frame: Week 24 ]Participants who will undergo revascularization procedures for the treatment of PAD will be reported.
- Change From Baseline in 36-Item Short Form Survey (SF-36) at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]SF-36 participant-reported measure of health-related quality of life. It consists of 8 sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, that are the weighted sums of the questions in each health domain. Each scale is directly transformed to a 0 to 100 scale on the assumption that each question carries equal weight. The lower the score, the more disability, and the higher the score, the less disability, that is, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469349
|Study Director:||Medical Director Clinical Science||Takeda|