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Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

Primary Purpose

Fibrillation, Atrial, Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB424323
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fibrillation, Atrial focused on measuring non valvular atrial fibrillation, stroke, aspirin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with non valvular atrial fibrillation and any of the following: </= 60 years old with no heart disease. 60 years old with heart disease but no risk factors. >/=60 years old and </=75 years old with no risk factors and no heart disease. Must be able to take aspirin. Exclusion Criteria: Previous heart attack or stroke. History of high blood pressure, diabetes or a prior blood clot. Liver or kidney disease. Need for anti-thrombotic or anti-platelet drugs. Need for cardiovascular medicines.

Sites / Locations

  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Outcome Measures

Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.

Full Information

First Posted
October 14, 2005
Last Updated
January 13, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00240643
Brief Title
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
Official Title
A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.
Detailed Description
A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrillation, Atrial, Atrial Fibrillation
Keywords
non valvular atrial fibrillation, stroke, aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB424323
Primary Outcome Measure Information:
Title
Relationship between anti IIa (a biomarker)and the dose of SB424323.
Secondary Outcome Measure Information:
Title
Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non valvular atrial fibrillation and any of the following: </= 60 years old with no heart disease. 60 years old with heart disease but no risk factors. >/=60 years old and </=75 years old with no risk factors and no heart disease. Must be able to take aspirin. Exclusion Criteria: Previous heart attack or stroke. History of high blood pressure, diabetes or a prior blood clot. Liver or kidney disease. Need for anti-thrombotic or anti-platelet drugs. Need for cardiovascular medicines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
GSK Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
GSK Investigational Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
GSK Investigational Site
City
Capital Fefderal
State/Province
Buenos Aires
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
5003
Country
Argentina
Facility Name
GSK Investigational Site
City
Córdoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Facility Name
GSK Investigational Site
City
Moron-Provincia de Buenos Aires
ZIP/Postal Code
1709
Country
Argentina
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
GSK Investigational Site
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
GSK Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
40110-160
Country
Brazil
Facility Name
GSK Investigational Site
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 5R3
Country
Canada
Facility Name
GSK Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
GSK Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
GSK Investigational Site
City
Grimsby
State/Province
Ontario
ZIP/Postal Code
L3M 1P3
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3B6
Country
Canada
Facility Name
GSK Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8C3
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
GSK Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
GSK Investigational Site
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4K 1E3
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
GSK Investigational Site
City
St-Lambert
State/Province
Quebec
ZIP/Postal Code
J4P 2H4
Country
Canada
Facility Name
GSK Investigational Site
City
Trois Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
GSK Investigational Site
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
GSK Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
GSK Investigational Site
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
GSK Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
GSK Investigational Site
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
GSK Investigational Site
City
Kuenzing
State/Province
Bayern
ZIP/Postal Code
94550
Country
Germany
Facility Name
GSK Investigational Site
City
Northeim
State/Province
Niedersachsen
ZIP/Postal Code
37154
Country
Germany
Facility Name
GSK Investigational Site
City
Weyhe-Leeste
State/Province
Niedersachsen
ZIP/Postal Code
28844
Country
Germany
Facility Name
GSK Investigational Site
City
Wolmirstedt
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39326
Country
Germany
Facility Name
GSK Investigational Site
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09113
Country
Germany
Facility Name
GSK Investigational Site
City
Ebersbach
State/Province
Sachsen
ZIP/Postal Code
02730
Country
Germany
Facility Name
GSK Investigational Site
City
Koenigsbrueck
State/Province
Sachsen
ZIP/Postal Code
01936
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04177
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04299
Country
Germany
Facility Name
GSK Investigational Site
City
Leisnig
State/Province
Sachsen
ZIP/Postal Code
04703
Country
Germany
Facility Name
GSK Investigational Site
City
Markkleeberg
State/Province
Sachsen
ZIP/Postal Code
04416
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Segeberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23795
Country
Germany
Facility Name
GSK Investigational Site
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07743
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
123 51
Country
Greece
Facility Name
GSK Investigational Site
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
GSK Investigational Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
GSK Investigational Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
GSK Investigational Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
GSK Investigational Site
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
GSK Investigational Site
City
Bangalore
Country
India
Facility Name
GSK Investigational Site
City
Hyderabad
ZIP/Postal Code
500063
Country
India
Facility Name
GSK Investigational Site
City
Mumbai
ZIP/Postal Code
400008
Country
India
Facility Name
GSK Investigational Site
City
New Delhi
ZIP/Postal Code
110065
Country
India
Facility Name
GSK Investigational Site
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
GSK Investigational Site
City
Caserta
State/Province
Campania
ZIP/Postal Code
81100
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00163
Country
Italy
Facility Name
GSK Investigational Site
City
Città della Pieve (PG)
State/Province
Umbria
ZIP/Postal Code
06062
Country
Italy
Facility Name
GSK Investigational Site
City
Kwangju
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV1001
Country
Latvia
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
GSK Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Auckland
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Takapuna, Auckland
ZIP/Postal Code
1309
Country
New Zealand
Facility Name
GSK Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0160
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
N-3710
Country
Norway
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
GSK Investigational Site
City
Bucuresti
Country
Romania
Facility Name
GSK Investigational Site
City
Targu-Mures
Country
Romania
Facility Name
GSK Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
GSK Investigational Site
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
GSK Investigational Site
City
Leganes
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
San Juan De Alicante
ZIP/Postal Code
3550
Country
Spain
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-111 57
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
GSK Investigational Site
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 1QL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Antrim
ZIP/Postal Code
BT41 2RL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

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