Fibrillation, AtrialPhase 2NCT00240643
Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke
A Phase 2 study testing SB424323 in people with Fibrillation, Atrial and Atrial Fibrillation, run by GlaxoSmithKline at 116 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibrillation, Atrial, Atrial Fibrillation
- What is being tested?
- SB424323
- How many people
- 640 participants
- Where
- 116 sitesin 25 countries
- Study dates
- Nov 2005to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
116 sites in 25 countries.
116 sites in 25 countries
Germany15 sites
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 12163
GSK Investigational Site
Chemnitz, Saxony, 09113
GSK Investigational Site
Ebersbach, Saxony, 02730
GSK Investigational Site
Jena, Thuringia, 07743
GSK Investigational Site
Königsbrück, Saxony, 01936
GSK Investigational Site
Künzing, Bavaria, 94550
GSK Investigational Site
Leipzig, Saxony, 04177
GSK Investigational Site
Leipzig, Saxony, 04299
GSK Investigational Site
Leisnig, Saxony, 04703
GSK Investigational Site
Markkleeberg, Saxony, 04416
GSK Investigational Site
Northeim, Lower Saxony, 37154
GSK Investigational Site
Weyhe-Leeste, Lower Saxony, 28844
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326
Canada12 sites
GSK Investigational Site
Burlington, Ontario, L7M 4Y1
GSK Investigational Site
Greenfield Park, Quebec, J4V 2G8
GSK Investigational Site
Grimsby, Ontario, L3M 1P3
GSK Investigational Site
Halifax, Nova Scotia, B3K 5R3
GSK Investigational Site
Hamilton, Ontario, L8P 3B6
GSK Investigational Site
Longueuil, Quebec, J4K 1E3
GSK Investigational Site
Montreal, Quebec, H2L 4M1
GSK Investigational Site
Newmarket, Ontario, L3Y 8C3
GSK Investigational Site
Saint-Lambert, Quebec, J4P 2H4
GSK Investigational Site
Toronto, Ontario, M3J 1N2
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
Argentina10 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1704
GSK Investigational Site
Buenos Aires, 1221
GSK Investigational Site
Buenos Aires, 1405
GSK Investigational Site
Buenos Aires, 1428
GSK Investigational Site
Capital Federal, Buenos Aires, C1180AAX
GSK Investigational Site
Capital Fefderal, Buenos Aires
GSK Investigational Site
Córdoba, Córdoba Province, 5000
GSK Investigational Site
Córdoba, Córdoba Province, 5003
GSK Investigational Site
Moron-Provincia de Buenos Aires, 1709
GSK Investigational Site
Rosario, Santa Fe Province, 2000
United States9 sites
GSK Investigational Site
Akron, Ohio, 44313
GSK Investigational Site
Camp Hill, Pennsylvania, 17011
GSK Investigational Site
Cincinnati, Ohio, 45224
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Milwaukee, Wisconsin, 53215
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Troy, Michigan, 48098
GSK Investigational Site
Walla Walla, Washington, 99362
Spain9 sites
GSK Investigational Site
Alicante, 03010
GSK Investigational Site
Alicante, 03114
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Cadiz, 11009
GSK Investigational Site
Leganés
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Sant Joan d'Alacant, 3550
United Kingdom8 sites
GSK Investigational Site
Antrim, BT41 2RL
GSK Investigational Site
Birmingham, West Midlands, B18 7QH
GSK Investigational Site
Dundee, DD1 9SY
GSK Investigational Site
Glasgow, Lanarkshire, G11 6NT
GSK Investigational Site
Harrow, Middlesex, HA1 1QL
GSK Investigational Site
Manchester, M23 9LT
GSK Investigational Site
Northwood, Middlesex, HA6 2RN
GSK Investigational Site
York, YO31 8HE
India5 sites
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Bangalore
GSK Investigational Site
Hyderabad, 500063
GSK Investigational Site
Mumbai, 400008
GSK Investigational Site
New Delhi, 110065
France4 sites
GSK Investigational Site
Créteil, 94000
GSK Investigational Site
Mont-de-Marsan, 40000
GSK Investigational Site
Toulouse, 31300
GSK Investigational Site
Tours, 37000
Hungary4 sites
GSK Investigational Site
Sopron, 9400
GSK Investigational Site
Székesfehérvár, 8000
GSK Investigational Site
Szolnok, 5000
GSK Investigational Site
Szolnok, 5004
Italy4 sites
GSK Investigational Site
Caserta, Campania, 81100
GSK Investigational Site
Catanzaro, Calabria, 88100
GSK Investigational Site
Città Della Pieve (PG), Umbria, 06062
GSK Investigational Site
Rome, Lazio, 00163
New Zealand4 sites
GSK Investigational Site
Auckland
GSK Investigational Site
Christchurch, 8001
GSK Investigational Site
Hamilton, 2001
GSK Investigational Site
Takapuna, Auckland, 1309
South Korea4 sites
GSK Investigational Site
Kwangju
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 152-703
Netherlands3 sites
GSK Investigational Site
Delft, 2625 AD
GSK Investigational Site
The Hague, 2597 AX
GSK Investigational Site
Utrecht, 3582 KE
Norway3 sites
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Oslo, N-0160
GSK Investigational Site
Skien, N-3710
Romania3 sites
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Bucharest
GSK Investigational Site
Târgu Mureş
Sweden3 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Stockholm, SE-111 57
GSK Investigational Site
Uppsala, SE-751 85
Belgium2 sites
GSK Investigational Site
Antwerp, 2020
GSK Investigational Site
Linkebeek, 1630
Brazil2 sites
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 40110-160
GSK Investigational Site
São Paulo, São Paulo, 04024-002
Denmark2 sites
GSK Investigational Site
Aarhus, DK-8000
GSK Investigational Site
Frederiksberg, 2000
Estonia2 sites
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
Greece2 sites
GSK Investigational Site
Athens, 115 28
GSK Investigational Site
Athens, 123 51
Latvia2 sites
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV1001
Thailand2 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Chiang Mai, 50200
About this study
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
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.
Read the 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
- Conditions
- Fibrillation, Atrial, Atrial Fibrillation
- Being tested
- SB424323
- Keywords
- non valvular atrial fibrillation, stroke, aspirin
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB424323Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between anti IIa (a biomarker)and the dose of SB424323.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240643
- Sponsor's protocol ID
- 101724
- Status last verified
- Jan 2017
- First submitted
- 14 Oct 2005
- Last updated
- 16 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00240643
- Acronym / sponsor ID
- 101724
- Conditions
- Fibrillation, Atrial, Atrial Fibrillation
- Keywords
- non valvular atrial fibrillation, stroke, aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB424323 | Drug | – |
Primary outcome
Relationship between anti IIa (a biomarker)and the dose of SB424323.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Related trials for Fibrillation, Atrial
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
116 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB424323 in people with Fibrillation, Atrial and Atrial Fibrillation, run by GlaxoSmithKline at 116 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in Germany, Canada, Argentina, United States, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between anti IIa (a biomarker)and the dose of SB424323.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.