Daiichi Sankyo Initiates Phase III Trial of Its Investigational Factor Xa Inhibitor, DU-176b, in Patients With Atrial Fi... ( TOKYO and EDISON N.J. Dec. 7 /- Daiic...)

HOME >> MEDICINE >> TECHNOLOGY

Daiichi Sankyo Initiates Phase III Trial of Its Investigational Factor Xa Inhibitor, DU-176b, in Patients With Atrial Fibrillation

Date:12/7/2008

TOKYO and EDISON, N.J., Dec. 7 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited (TSE: 4568), announced today that it has initiated its pivotal Phase III trial for DU-176b, an investigational oral Factor Xa inhibitor, in patients with atrial fibrillation. DU-176b is being developed solely by Daiichi Sankyo.

The Phase III global study, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE-AF TIMI 48), will compare DU-176b with warfarin in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation. The primary safety assessment will be the incidence of bleeding.

Results from a recently presented Phase II safety study showed that the incidence of major and clinically relevant non-major bleeding events reported in the once-daily DU-176b treatment groups (30 mg or 60 mg) was similar to that in the warfarin-treated patient group. The incidence of major and clinically relevant non-major bleeding events was significantly higher in the twice-daily DU-176b treatment groups (30 mg or 60 mg), compared to the warfarin group. The Phase III study will therefore randomize approximately 16,500 patients to one of three treatment groups: 30 mg DU-176b once daily, 60 mg DU-176b once daily, or warfarin. Those randomized to warfarin will be dosed once daily with dose adjustments to maintain International Normalized Ratio (INR) between 2.0 and 3.0.

This is an event-driven, Phase III, multinational, randomized, double-blind study with sites in North and South America, Africa, Asia, Europe, Australia and New Zealand. The expected median treatment duration of the study is 24 months; Daiichi Sankyo expects the study to conclude in the first half of 2012.

"There is a need for a safe and effective option for the prevention of clotting or stroke in patients with atrial fibrillation other than the current standard of care, warfarin, which
'/>"/>

0

GOOD

Page: 1 2 3 4
Related medicine technology :

1. Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application
2. Daiichi Sankyo Announces Clinical Study Data for Oral Factor Xa Inhibitor DU-176b
3. FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
4. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
5. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
6. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
7. Enobia Initiates Infantile Enzyme Replacement Trial for Rare Bone Disease
8. PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)
9. Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel Hypertension Drug, ADX415
10. CeNeRx BioPharma Initiates Phase II Clinical Trial of Its Novel Antidepressant Agent Tyrima(TM)
11. Insmed Initiates Clinical Study for Follow-on Biologic Version of Neulasta(R)

Post Your Comments:

Daiichi Sankyo Initiates Phase III Trial of Its Investigational Factor Xa Inhibitor, DU-176b, in Patients With Atrial Fi...( TOKYO and EDISON N.J. Dec. 7 /- Daiic...),Health