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ataciguat

Phase 2

Intermittent Claudication | Small molecule | Other |Sanofi|Last Updated: May 17, 2018

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 Enrollment553
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00443287Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial DiseasePHASE2 COMPLETED 553Feb 1, 2007Oct 1, 2008May 17, 20187 United States, Austria +5
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Study Endpoints
Primary Endpoints
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
26 weeks
Secondary Endpoints
Secondary efficacy endpoint: percent change in the absolute claudication distance
26 weeks
Safety endpoints: adverse events
study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTALdose level 1
3EXPERIMENTALdose level 2
4EXPERIMENTALdose level 3
5ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ataciguat (HMR1766)DRUGoral administration
placeboDRUGoral administration
cilostazolDRUGoral administration
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months) * Initial claudica...

Countries:United StatesAustriaCanadaFrancePolandRussiaSouth Africa
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