Clinical Trials

Date: 2014-08-29

Type of information: Initiation of the trial

phase: 2-3

Announcement: initiation of the development program

Company: Janssen Research & Development, a J&J company (USA - NJ) - Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease: acute coronary syndrome (ACS, stroke of undetermined source (ESUS) - peripheral artery disease (PAD)

Therapeutic area: Cardiovascular diseases

Country:

Trial details:

The new trials initiated by Janssen and its development partner, Bayer HealthCare, are:
GEMINI 1 & 2 ACS, a global indication-seeking clinical program, designed to evaluate rivaroxaban in patients who suffer from acute coronary syndrome (ACS). The program will launch with GEMINI 1 ACS, to investigate the benefits of the dual pathway strategy of anticoagulation with rivaroxaban in combination with a single antiplatelet agent for long-term secondary prevention of additional cardiovascular events in patients with ACS. The study will include 2,000 to 3,000 patients in more than 10 countries. If successful, the Phase 2 study will be followed by GEMINI 2 ACS, a global Phase 3 study. The GEMINI ACS program builds off the global 19,000 patient ATLAS ACS 2-TIMI 51 trial, which showed treatment with XARELTO® resulted in reductions in important cardiovascular events.
NAVIGATE ESUS, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with embolic stroke of undetermined source (ESUS). The study will include at least 7,000 patients in more than 25 countries.
VOYAGER PAD, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with peripheral artery disease (PAD) undergoing peripheral artery interventions. The study will include at least 5,000 patients in more than 20 countries.

Latest news:

• On August 29, 2014, Janssen Research & Development and its development partner, Bayer HealthCare, announced the expansion of the EXPLORER global cardiovascular research program for Xarelto® (rivaroxaban) to include additional high-risk patient populations. New trials will investigate rivaroxaban, for the treatment of acute coronary syndrome (ACS), embolic stroke of undetermined source (ESUS) and peripheral artery disease (PAD). If this research is successful, Janssen may seek FDA approval of Xarelto® for these indications.