Clinical trial NCT00504556: A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Official title: A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Thromboembolism
Keywords: Anti-coagulant
Non-valvular
Venous Thromboembolism
Prevention of Blood Clots
Atrial Fibrillation
Non-valvular atrial fibrillation
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 1146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 to 80 years old.
2. Able to provide written informed consent.
3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion Criteria:

1. Subjects with mitral valve disease or previous valvular heart surgery
2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
3. Known or suspected hereditary or acquired bleeding or coagulation disorder

Primary outcomes:
measure: Adjudicated Incidence of Bleeding Events
timeFrame: 3 months
measure: Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of Major Adverse Cardiac Events MACE)
timeFrame: 3 months
measure: Effects on Biomarker D-dimer
timeFrame: 3 months
measure: Effects on Biomarker Prothrombin Fragments
timeFrame: 3 months
measure: Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b
timeFrame: 3 months
measure: Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b
timeFrame: 3 months
measure: Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b
timeFrame: Day 28
measure: Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b
timeFrame: Day 28
measure: Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b
timeFrame: Day 28
measure: Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b
timeFrame: Day 28
measure: Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b
timeFrame: Day 28
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Stockton
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Canton
country: United States
state: Georgia
city: Fort Wayne
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Cadillac
country: United States
state: Michigan
city: Kalispell
country: United States
state: Montana
city: Fremont
country: United States
state: Nebraska
city: Santa Fe
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Pottstown
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Bellevue
country: United States
state: Washington
city: Minsk
country: Belarus
city: Brussels
country: Belgium
city: Genk
country: Belgium
city: Banja Luka
country: Bosnia and Herzegovina
city: Mostar
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Alberta
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Oshawa
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Antofagasta
country: Chile
city: Osorno
country: Chile
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Ventspils
country: Latvia
city: Cordoba
country: Mexico
city: Guadalajara Jalisco
country: Mexico
city: Mexico City
country: Mexico
city: Chisinau
country: Moldova, Republic of
city: Arkhangelsk
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Kaliningrad
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: N.Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Penza
country: Russian Federation
city: Perm
country: Russian Federation
city: Rostov on Don
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tula
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bardejov
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Lucenec
country: Slovakia
city: Presov
country: Slovakia
city: Cherkassy
country: Ukraine
city: Chernigov
country: Ukraine
city: Chernivtsy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporozhye
country: Ukraine
Study officials:
References: