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Cilastatin

Phase 3

Bacterial Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 4, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment430
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00080496Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired PneumoniaPHASE3 COMPLETED 430 — — Jul 1, 2003Dec 1, 2006Aug 4, 200829 United States
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Study Endpoints
Primary Endpoints
The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TigecyclineDRUG -
ImipenemDRUG -
CilastatinDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age. * Subjects known or suspected to have acute hospital-acquired pneumonia. Exclusion Criteria: * Presence of any of the following pulmonary cond...

Countries:United States
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