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clarithromycin

Phase 3

Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 26, 2008

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 Enrollment504
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00643227A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult PatientsPHASE3 COMPLETED 504Jan 1, 2003Mar 1, 2004Mar 26, 200872 United States, Argentina +6
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Study Endpoints
Primary Endpoints
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Test of Cure (TOC) visit (Day 14-21)
Secondary Endpoints
bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
TOC visit
sponsor assessment of clinical response by baseline pathogen
End of Treatment (EOT) visit (Day 8-11) and TOC visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
clarithromycin extended release (ER)DRUG7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
azithromycin SRDRUGSingle, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites72

Inclusion Criteria: Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell c...

Countries:United StatesArgentinaCanadaEstoniaIndiaLithuaniaRussia
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