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WS 1442 /d

Phase 1

Overweight | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: May 14, 2014

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00982501WS®1442 in Slightly Overweight SubjectsPHASE1 COMPLETED 60Jun 1, 2008Feb 1, 2011May 14, 20141 Austria
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Study Endpoints
Primary Endpoints
Adverse events
12 weeks
Lab parameters
12 weeks
Vital signs
12 weeks
Treadmill test including lactate measurement
12 weeks
Secondary Endpoints
Endothelial function
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
WS® 1442 900 mgEXPERIMENTAL -
WS® 1442 1800 mgEXPERIMENTAL -
Nordic walking training 2x30 minACTIVE_COMPARATOR -
Nordic walking training 4x45 minACTIVE_COMPARATOR -
Interventions
NameTypeDescription
WS® 1442 900 mg/dDRUG -
WS® 1442 1800 mg/dDRUG -
Nordic walking training 2 x 30 min/weekBEHAVIORAL -
Nordic walking training 4x45 min/weekBEHAVIORAL -
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Eligibility Criteria
Age Range45 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * written informed consent * male and female subjects aged 45-75 years * untrained * BMI between 25 and 29,9 kg/m² * resting blood pressure in sitting position ≤ 140/90 mmHg * inconspicuous ergometry Exclusion Criteria: * pregnancy or breastfeeding * any other current medicati...

Countries:Austria
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