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Korean Red Ginseng, Corn Starch

Phase 2

Hypertension | Unknown | Cardiovascular |Unity Biotechnology, Inc.|Last Updated: Jul 31, 2015

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-BlindCONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00730951The Evaluation and Standardization of Ginseng and Its Components for Blood Pressure RegulationPHASE2 COMPLETED 18Jun 1, 2007Mar 1, 2008Jul 31, 20151 Canada
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Study Endpoints
Primary Endpoints
Blood Pressure will be measured with an Ambulatory Blood Pressure Monitor
every 5 min for first 30 min, then every 10 minutes for 180 minutes
Secondary Endpoints
Blood samples will be drawn and tested for Nitric Oxide levels.
every 30 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL0.5g Korean Red Ginseng (1 capsule) 5.5g Corn Starch (11 capsules)
2EXPERIMENTAL1g Korean Red Ginseng (2 capsules) 5g Corn Starch (10 capsules)
3EXPERIMENTAL3g Korean Red Ginseng (6 capsules) 3g Corn Starch (6 capsules)
4EXPERIMENTAL6g Korean Red Ginseng (12 capsules)
5EXPERIMENTAL6g Corn Starch Control (12 capsules)
Interventions
NameTypeDescription
Korean Red GinsengDIETARY_SUPPLEMENT500mg Capsulated Ground Dried Korean Red Ginseng Root
Corn StarchDIETARY_SUPPLEMENT500mg Capsulated Corn Starch
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Essential Hypertension Exclusion Criteria: * Secondary Hypertension * Diabetes * Chronic Kidney Disease * Liver Disease * Unstable Angina * Coronary / Cerebrovascular event in the previous 6 months

Countries:Canada
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