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Telithromycin

Phase 3

Asthma | Small molecule | Respiratory |Sanofi|Last Updated: Sep 15, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00273520TELICAST : Telithromycin in Acute Exacerbations of AsthmaPHASE3 COMPLETED -Jan 1, 2003May 1, 2004Sep 15, 2009 -
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Study Endpoints
Primary Endpoints
Patient's daily diary summary symptom scores/Morning diary PEFR
During the Study Conduct
Secondary Endpoints
In-clinic pulmonary function tests: Forced expiratory volume in 1 second (FEV1), Percent predicted FEV1, Forced vital capacity (FVC), Forced expiratory flow rate at 25% to 75% of FVC (FEF25-75), PEFR, and percent predicted PEFR
During the study conduct
Evening diary PEFR, and diary PEFR variability
During the study conduct
Time to symptom resolution from study entry acute exacerbation of asthma
During the study conduct
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TelithromycinDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion criteria Patients meeting all of the following criteria will be considered for enrollment in the study: * A documented history of asthma for \>6 months * Presenting within 24 hours of initial medical care in an urgent care clinic, emergency room, or in-patient hospital setting. To qualif...

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