Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 Post-Stroke Cognitive Impairment (PSCI) and Peripheral Arterial Diseases. It is in Phase 3 clinical development for these conditions. Actovegin is not approved and remains under investigation in clinical trials.
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 in patients with Post-Stroke Cognitive Impairment and Peripheral Arterial Diseases.
Actovegin is in Phase 3 clinical development. Two Phase 3 trials have been completed, one in Post-Stroke Cognitive Impairment and one in Peripheral Arterial Occlusive Disease. The drug is investigational and has not been approved for any use.
Actovegin has completed two Phase 3 trials. NCT01582854 studied Actovegin in 503 patients with Post-Stroke Cognitive Impairment in Belarus, Kazakhstan, and Russia. NCT03469349 studied Actovegin in 366 patients with Peripheral Arterial Occlusive Disease in Georgia, Kazakhstan, and Russia.
Actovegin is a distinct drug candidate developed by Takeda. It is not known to be the same as any other marketed drug. Its active component is derived from calf blood, but no alternative names have been established in clinical literature.