Recent Updates
Recently added Catalysts

rolofyline

Phase 2

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

rolofyline development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2008

rolofyline target and mechanism

ModalitySmall molecule

Also known as MK7418

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

rolofyline clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Frequently asked questions about rolofyline

What is rolofyline used for?

Rolofyline is an investigational small molecule being studied for congestive heart failure, including in patients with renal impairment. It was evaluated in a Phase 2 trial examining its effects on diuresis and renal function. It is not an approved therapy and remains in clinical development.

Who is developing rolofyline?

Rolofyline is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 2 clinical program for the drug in congestive heart failure.

What phase is rolofyline in?

Rolofyline is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials has rolofyline been studied in?

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

Is rolofyline the same as MK7418?

Yes, MK7418 is an alternative name for rolofyline. The Phase 2 trial NCT00652782 was conducted under the MK7418 designation, so searches for either name refer to the same Merck investigational compound for congestive heart failure.