Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients

A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652782

Enrollment

160

Registered

2008-04-04

Start date

2004-12-31

Completion date

Unknown

Last updated

2008-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Renal Impairment

Brief summary

A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.

Interventions

DRUGrolofyline

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

DRUGComparator Placebo (unspecified)

Matching placebo for rolofyline IV QD; 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 hours of the mandatory dose of IV furosemide 40 mg at between 2000 and 2200 hour on Day -1

Exclusion criteria

* Have had a myocardial infarction within 30 days prior to Day -1 * Be pregnant or breast-feeding * Have received intravascular contrast material within the preceding 14 days; or have acute contrast nephropathy * Have had implantation of an automated implanted cardiac defibrillator (AICD) or synchronization device within the preceding 7 days * Currently require mechanical ventilation, ultrafiltration, or hemodialysis, * Have symptomatic ventricular tachycardia * Be admitted for heart transplant surgery or have had a heart transplant, * Have any other concomitant life-threatening disease, * Have participated in a clinical trial of an investigational drug or device within 30 days before randomization * Have a positive urine pregnancy test (for women of child-bearing capacity) * Have an allergy to soybean oil and/or eggs

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026