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rolofyline

Phase 2

Congestive Heart Failure | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Apr 4, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

rolofyline · 1 trial · 2 indications

Phase 2 1
NCT00652782Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure PatientsCongestive Heart Failure
COMPLETED160 Analytics
PHASE2COMPLETED
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
Congestive Heart FailureUnlock trial analytics

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 to 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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Frequently asked questions about rolofyline

What is rolofyline used for?

Rolofyline is an investigational small molecule being studied for congestive heart failure, a condition in which the heart cannot pump blood effectively. It is being developed as a potential treatment to address fluid retention and related symptoms in patients with this condition.

Who makes rolofyline?

Rolofyline is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with congestive heart failure.

What phase is rolofyline in?

Rolofyline is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in treating congestive heart failure.

What clinical trials is rolofyline in?

Rolofyline has been studied in one completed Phase 2 clinical trial registered as NCT00652782, titled 'Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients.' The trial enrolled 160 participants with congestive heart failure and renal impairment, was randomized, double-blind, and placebo-controlled.

Is rolofyline the same as MK7418?

Yes, rolofyline is also known as MK7418. The clinical trial NCT00652782 refers to the drug as MK7418, which is the same investigational compound being developed by Merck & Company, Inc. for congestive heart failure.

How does rolofyline work?

Rolofyline is a small molecule designed to target mechanisms involved in fluid regulation in the body. In the context of congestive heart failure, it is being studied for its effects on diuresis, or urine production, and renal function, which are important for managing fluid overload in patients.