Approval Probability
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Actovegin · 2 trials · 2 indications
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.
The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement. Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate.
| Arm | Type | Description |
|---|---|---|
| Actovegin 1200 mg | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | Actovegin placebo-matching, intravenously, once daily for up to 2 weeks and actovegin placebo-matching tablets, orally, TID for up to 10 weeks. |
| Actovegin | ACTIVE_COMPARATOR | Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months. |
| Name | Type | Description |
|---|---|---|
| Actovegin | DRUG | Actovegin intravenous infusion and tablets. |
| Placebo | DRUG | Actovegin placebo-matching intravenous infusion and tablets. |
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 ultrasou...
Actovegin is an investigational small molecule being studied for peripheral arterial diseases and post-stroke cognitive impairment (PSCI). In clinical trials, it has been evaluated for post-stroke cognitive impairment and peripheral arterial occlusive disease Fontaine stage IIB.
Actovegin is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its effects on peripheral arterial diseases and post-stroke cognitive impairment.
Actovegin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's efficacy and safety.
Actovegin is in Phase 3 clinical development. It is investigational and not yet approved, with completed Phase 3 trials in post-stroke cognitive impairment and peripheral arterial occlusive disease.
Actovegin has completed two Phase 3 trials: NCT01582854 in post-stroke cognitive impairment with 503 participants, and NCT03469349 in peripheral arterial occlusive disease with 366 participants. Both were randomized, double-blind, and placebo-controlled.
Actovegin is not known by any alternative names. It is a distinct investigational drug being developed by Takeda for cardiovascular and neurological conditions.