Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ticlopidine · 2 trials · 3 indications
Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
| Arm | Type | Description |
|---|---|---|
| Clopidogrel | EXPERIMENTAL | 75 mg clopidogrel once daily from Day 1 to Week 12 |
| Ticlopidine | ACTIVE_COMPARATOR | 200 mg ticlopidine once daily from Day 1 to Week 12 |
| Name | Type | Description |
|---|---|---|
| clopidogrel (SR25990) | DRUG | oral administration (tablets) |
| ticlopidine | DRUG | oral administration (tablets) |
| Placebo | DRUG | Form: tablets Route: oral |
Inclusion Criteria: Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied): * Current intermittent claudication with Ankle Brachial Index (ABI) \< 0.90 * A history of intermittent claudication together with previous related interven...
Ticlopidine is used for cardiovascular conditions, including Peripheral Arterial Disease (PAD) and Stable Angina. It is a small molecule being developed by Sanofi. In clinical trials, it has been evaluated in patients with stable angina and old myocardial infarction, as well as in patients with peripheral arterial disease.
Ticlopidine is developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical development of ticlopidine for cardiovascular indications, including Peripheral Arterial Disease and Stable Angina.
Ticlopidine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for ticlopidine have been completed, with no active trials currently ongoing.
Ticlopidine has been studied in completed Phase 3 trials. One trial, NCT00821834, evaluated ticlopidine in patients with stable angina or old myocardial infarction undergoing planned percutaneous coronary intervention. Another trial, NCT00862420, assessed ticlopidine in patients with Peripheral Arterial Disease. Both trials were conducted in Japan.
Ticlopidine is not the same as clopidogrel. While both are antiplatelet agents, ticlopidine is a distinct drug. Clinical trials for ticlopidine have been conducted with active controls, meaning ticlopidine was compared against another treatment, but ticlopidine itself is a separate medication.