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vitamin B6

Phase 3

Coronary Artery Disease | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Jul 12, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment3,096
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00354081WENBIT - Western Norway B Vitamin Intervention TrialPHASE3 COMPLETED 3,096Apr 1, 1999Feb 1, 2008Jul 12, 20132 Norway
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Study Endpoints
Primary Endpoints
Composite of all cause death, non-fatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and of non-fatal thromboembolic stroke (infarction)
During follow-up, 1.5-5 years
Secondary Endpoints
Fatal and non-fatal acute myocardial infarction, including procedure related myocardial infarction
During follow-up, 1.5-5 years
Acute hospitalization for angina
During follow-up, 1.5-5 years
Stable angina with angiographic verified progression
During follow-up, 1.5-5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORfolic acid (0.8 mg) plus vitamin B12 (0.4 mg) and vitamin B6 (40 mg)
2ACTIVE_COMPARATORfolic acid (0.8 mg) plus vitamin B12 (0.4 mg)
3ACTIVE_COMPARATORvitamin B6 (40 mg)
4PLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
folic acid, vitamin B12 (cyanocobalamin), vitamin B6 (pyridoxine)DRUGfolic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg, in a capsule, taken orally once a day
folic acid, vitamin B12 (cyanocobalamin)DRUGfolic acid 0.8 mg plus vitamin B12 0.4 mg, in a capsule, taken orally once a day
vitamin B6 (pyridoxine)DRUGvitamin B6 40 mg, in a capsule, taken orally once a day
placeboDRUGplacebo, in a capsule, taken orally once a day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * adults ≥ 18 years able to give informed consent * patients prepared to undergo long-term follow-up * patients with and without significant coronary artery disease (CAD) who have undergone coronary angiography just before inclusion Exclusion Criteria: * patients who are not a...

Countries:Norway
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