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MK633

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Sep 3, 2015

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 Enrollment266
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00418613A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)PHASE2 COMPLETED 266Jan 1, 2008Mar 1, 2009Sep 3, 2015 -
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Study Endpoints
Primary Endpoints
Pulmonary function test data
Measured over 12 weeks
Secondary Endpoints
Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score
Measured over 12 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMK0633
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
MK633DRUGMK0633 100mg capsules qd for a 12-wk treatment period.
Comparator: Placebo (unspecified)DRUGMK0633 100mg Pbo capsules for a 12-wk treatment period
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening * Male or postmenopausal females 40 -75 years of age Exclusion Criteria: * Impaired renal function * Histo...

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