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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03469349
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03469349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • 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 patient-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, ie, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
Official Title  ICMJE 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
Brief 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.
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:

  1. Actovegin
  2. 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Diseases
Intervention  ICMJE
  • Drug: Actovegin
    Actovegin intravenous infusion and tablets.
  • Drug: Placebo
    Actovegin placebo-matching intravenous infusion and tablets.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Actovegin
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2018)
366
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 20, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Has a history of stable intermittent claudication lasting more than 6 months before Screening.
  2. 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.
  3. Has a resting Doppler ankle-brachial index of greater than or equal to (<=) 0.9.
  4. Has intermittent claudication with initial claudication distance (ICD) greater than (<) 200 meters.
  5. Is not newly diagnosed with PAD and has a history of stable PAD therapy for at least 2 weeks before Screening.

Exclusion Criteria:

  1. Has PAD Fontaine Stage III or IV (pain at rest, non-healing ulceration, or gangrene).
  2. Has evidence of nonatherosclerotic PAD.
  3. Has less than (>) 25 percent (%) variability in absolute claudication distance (ACD) based on treadmill testing during the screening period.
  4. Has lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within 3 months before Screening.
  5. Is eligible for surgical/interventional reconstruction.
  6. Had a myocardial infarction or major cardiac surgery within 3 months before Screening.
  7. Has congestive heart failure (New York Heart Association Class III/IV).
  8. Has uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c >9%]) or diabetic polyneuropathy.
  9. 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).
  10. The subject has received any prohibited medication within 14 days before Randomization (Day 1)
  11. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan,   Belarus,   Georgia,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03469349
Other Study ID Numbers  ICMJE Actovegin-3001
2017-004741-24 ( EudraCT Number )
U1111-1201-7990 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Takeda
PRS Account Takeda
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP