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Ivabradine

Phase 3

Postural Orthostatic Tachycardia Syndrome | Small molecule | Other |Amgen Inc.|Last Updated: Jun 29, 2021

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03182725Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia SyndromePHASE3 COMPLETED 37Feb 6, 2018May 8, 2020Jun 29, 20211 United States
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Study Endpoints
Primary Endpoints
Change in Heart Rate
Baseline and one month post-treatment

Orthostatic heart rate monitoring will be used to gauge heart rate changes.

Secondary Endpoints
Change in Quality of Life Via SF-36 Survey
Baseline and one month post-treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPatient will consume one placebo pill twice a day for one month.
IvabradineEXPERIMENTALPatient will consume one dose of Ivabradine twice a day for one month.
Interventions
NameTypeDescription
IvabradineDRUGIvabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
PlaceboDRUGA substance that has no therapeutic effect and will act as a control.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects aged 18-65. * Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE\> 600pg/ml)) * Subjects with no structural heart disease * Subject with no arrhythmias * Subjects with norepinephrine levels greater than 600 pg/ml * Subjects with normal CBC, Metabolic, ...

Countries:United States
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