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rolofyline

Phase 2

Congestive Heart Failure | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Apr 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00652782Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure PatientsPHASE2 COMPLETED 160Dec 1, 2004 -Apr 4, 2008 -
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Study Endpoints
Primary Endpoints
To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment
30 days
Secondary Endpoints
To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients
30 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALrolofyline 2.5 mg IV QD
2EXPERIMENTALrolofyline 15 mg IV QD
3EXPERIMENTALrolofyline 30 mg IV QD
4EXPERIMENTALrolofyline 60 mg IV QD
5PLACEBO_COMPARATORplacebo for rolofyline IV QD
Interventions
NameTypeDescription
rolofylineDRUGrolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
Comparator Placebo (unspecified)DRUGMatching placebo for rolofyline IV QD; 3 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Be able to provide written informed consent, * Be a male or female at least 18 years of age, * Be hospitalized for fluid overload requiring IV diuretic therapy * History of use of diuretic therapy for CHF (including this admission), * Be admitted to the hospital within 36 hour...

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