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Diuretics

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Diuretics · 1 trial · 1 indication

Phase 2 1
NCT01370564Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling PressuresHeart Failure
COMPLETED21 Analytics
PHASE2COMPLETED
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Heart FailureUnlock trial analytics

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 to 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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Frequently asked questions about Diuretics

What is Diuretics used for in Heart Failure?

Diuretics are being studied for use in Heart Failure. The investigational small molecule is in Phase 2 clinical development for this cardiovascular condition. A completed Phase 2 trial evaluated the feasibility of an integrated patient care system using daily filling pressures in patients with heart failure.

Who makes Diuretics?

Diuretics is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RYTM. The company is conducting clinical research on this small molecule for the treatment of heart failure.

What phase is Diuretics in?

Diuretics is in Phase 2 clinical development for Heart Failure. It is an investigational small molecule and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed, and the drug remains under investigation for this indication.

What clinical trials is Diuretics in?

Diuretics has one completed Phase 2 clinical trial, NCT01370564, titled 'Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures.' This trial enrolled 21 participants with Heart Failure in the United States and was not randomized or blinded.

Is Diuretics FDA approved?

Diuretics is not FDA approved. It is an investigational small molecule currently in Phase 2 clinical development for Heart Failure. The drug has completed one Phase 2 trial, but approval status has not been established, and it remains under clinical investigation.