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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 : Active, not recruiting
First Posted : March 19, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Diseases Drug: Actovegin Drug: Placebo Phase 3

Detailed Description:

The study will enroll approximately 366 patients. 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/IV infusion that looks like the study drug but has no active ingredient

All participants will be asked to take IV infusion for 2 weeks followed by oral tablets for 10 weeks.

This multi-center trial will be conducted Russia, Belarussia, Georgia, Ukraine and Kazakhstan. The overall time to participate in this study is 25-26 weeks. Participants will make multiple visits to the clinic, and 12 weeks after last dose of study drug for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Actovegin 1200 mg
Actovegin 1200 mg, intravenously (IV), 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.
Drug: Actovegin
Actovegin IV infusion and tablets

Placebo Comparator: Placebo
Actovegin placebo-matching, IV, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks.
Drug: Placebo
Actovegin placebo-matching IV infusion and tablets




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Is newly diagnosed with PAD or has a history of stable PAD therapy (including smoking status, exercise habits, and medications) for at least 3 months before randomization.
  4. Has a resting Doppler ankle-brachial index of ≤0.9.
  5. Has intermittent claudication with initial claudication distance (ICD) <200 meters.

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 >25% 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 a candidate for revascularization or angioplasty.
  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 that limits participation (in the judgement of the investigator).

Information from the National Library of Medicine

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


Locations
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Belarus
4-th N.E. Savchenko City Clinical Hospital
Minsk, Belarus, 220036
RSPC Cardiology
Minsk, Belarus, 220036
Minsk Region Clinical Hospital Department of vascular surgery
Minsk, Belarus, 223040
Georgia
High Technology Medical Center; University Clinic
Tbilisi, Georgia, 0144
Center of Vascular and Heart Disease
Tbilisi, Georgia, 0159
Aversi Clinic
Tbilisi, Georgia, 0160
Kazakhstan
"National scientific centre of oncology and transplantology"
Astana, Kazakhstan, Z05K4F3
Regional Clinic Hospital
Shymkent, Kazakhstan, X09E1G4
Russian Federation
NSHI Road clinical hospital at Chelyabinsk station of OAO RZD
Chelyabinsk, Russian Federation, 454092
BMH Kursk regional clinical hospital of Healthcare department of Kursk region
Kursk, Russian Federation, 305007
SBHI of Moscow city "City clinical hospital #29 n.a. N.E. Bauman of Moscow Healthcare department
Moscow, Russian Federation, 111020
SBHI of Moscow healthcare department City clinical hospital #15 n.a. O.M Filatov of Moscow healthcare department
Moscow, Russian Federation, 111539
A.V. Vishnevsky Institute of Surgery, vessel surgery department
Moscow, Russian Federation, 117997
SBHI of Moscow Research Institute of Emergency Medicine n.a. N.V. Sklifosofsky of Moscow Healthcare department
Moscow, Russian Federation, 129090
BHI of Omsk region Regional clinical hospital, vessel surgery department
Omsk, Russian Federation, 644111
FSBEI HE Rostov State Medical University of MoH of Russia
Rostov-on-Don, Russian Federation, 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, Russian Federation, 390026
Pavlov First Saint Petersburg State Medical University, Faculty surgery chair, cardio-vessel surgery department
Saint Petersburg, Russian Federation, 197022
SPb SBHI Consulting and diagnostic center #85
Saint Petersburg, Russian Federation, 198260
North-Western State Medical University named after I.I. Mechnikov
Saint-Petersburg, Russian Federation, 191015
SPb SBHI City multipurpose hospital #2
Saint-Petersburg, Russian Federation, 194354
State Healthcare Institution of Saratov region "Region clinical hospitai"
Saratov, Russian Federation, 410053
Ukraine
Regional Clinical Hospital, Department of Vascular Surgery
Dnipro, Ukraine, 49005
National Medical University of MoH of Ukraine, Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ukraine, 76008
Institute of General and Urgent Surgery of the National Academy of Sciences of Ukraine, department of acute vascular diseases
Kharkiv, Ukraine, 61103
National Medical University after O.O. Bogomolets, Aleksandrovskaya City Clinical Hospital Dpt of General Surgery
Kyiv, Ukraine, 01004
National Institute of Surgery &Transplantology, department of surgery of the main vessels
Kyiv, Ukraine, 03680
Lviv Regional Clinical Hospital, Department of Vascular Surgery
Lviv, Ukraine, 79000
Zaporizhzhia Regional Clinical Hospital, Regional center of vascular and endovascular surgery
Zaporizhzhia, Ukraine, 69050
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03469349     History of Changes
Other Study ID Numbers: Actovegin-3001
2017-004741-24 ( EudraCT Number )
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Actovegin
Central Nervous System Stimulants
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Radiation-Protective Agents