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Diuretics

Phase 2

Heart Failure | Small molecule | Cardiovascular |Rhythm Pharmaceuticals, Inc.|Last Updated: Jul 11, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01370564Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling PressuresPHASE2 COMPLETED 21Jun 1, 2011Jan 1, 2012Jul 11, 20183 United States
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Study Endpoints
Primary Endpoints
Characterize the Technical Feasibility of the Network Based IPC System
Baseline through Completion/Exit (an average of 3 months)

The proportion of study days a PtIS is based on the subjects' daily pressure state

Secondary Endpoints
Characterize the Rate of IPC Setup System Changes
Baseline through Completion/Exit (an average of 3-months)
Quantify Subject Compliance to Daily PtIS
Baseline through Completion/Exit (on average 3-months)
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Baseline through Completion/Exit (an average of 3-months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Daily diuretic adjustmentOTHERDaily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Interventions
NameTypeDescription
DiureticsDRUGDaily adjustments of diuretics and associated supplements based on cardiac filling pressures.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle ICD device (Model 7286) * Patients who have been prescribed daily diuretic therapy for the management of heart failure * Patients currently participating in the COMPASS-HF Extension Phase Stu...

Countries:United States
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