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

Browse trials for

• Peripheral Arterial Disease 1,538
• Peripheral Vascular Diseases 1,021
• Arterial Occlusive Diseases 296

Keywords

• Drug Therapy

Study arms

• 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.

  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.

  Drug: Placebo

Interventions

• DrugActovegin

  Actovegin intravenous infusion and tablets.

• DrugPlacebo

  Actovegin placebo-matching intravenous infusion and tablets.

Primary outcomes

1. Percent Change From Baseline in Initial Claudication Distance (ICD) at 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.

   Time frame: Baseline up to Week 12

Secondary outcomes

1. Percent Change From Baseline in ICD at 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.

   Time frame: Baseline up to Weeks 2 and 24

2. Absolute Change From Baseline in Absolute Claudication Distance (ACD) at 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.

   Time frame: Baseline, Weeks 2, 12 and 24

3. Percentage of Participants With Rest Pain at 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.

   Time frame: Weeks 12 and 24

4. Percentage of Participants With Revascularization Procedures at 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.

   Time frame: Week 24

5. Change From Baseline in 36-Item Short Form Survey (SF-36) at 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.

   Time frame: Baseline, Weeks 12 and 24

Baseline characteristics

4 further baseline measures are reported on the registry.

Study documents

• Study protocol · Feb 19, 2019
• Statistical analysis plan · Nov 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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