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GSK1014802

Phase 1

Healthy Volunteer | Small molecule | Other |Biogen Inc.|Last Updated: Oct 16, 2017

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00955396Study to Investigate the Effect of GSK1014802 on Ambulatory Blood PressurePHASE1 COMPLETED 60 — — Jul 31, 2009Dec 31, 2009Oct 16, 20171 United States
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Study Endpoints
Primary Endpoints
Change in 24 h average SBP and DBP from Baseline to Day 36.
36 days
Secondary Endpoints
Change in 24 h average SBP and DBP from Baseline to Day 15. Change in average SBP and DBP within a dosing interval (12 h) from Baseline to Days 14 and 35.
35 days
Change in 24 h average SBP and DBP from Baseline to Days 15 and 36 in subjects with baseline SBP 120-139 mmHg and also DBP 80-89 mmHg.
36 days
Change in day-time outpatient (6:00 AM to 10:00 PM) SBP and DBP from Baseline to Days 15 and 36.
36 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Period 1OTHER -
Period 2OTHER -
Interventions
NameTypeDescription
GSK1014802DRUGTablets
PlaceboDRUGTablets
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, liver function and cardiac monitoring. * A female subje...

Countries:United States
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