Skip to main content
OpenTrials
Completed

NCT Number: NCT00652782

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rolofyline

Drug

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

Other names: MK7418

Comparator Placebo (unspecified)

Drug

Matching placebo for rolofyline IV QD; 3 days

Primary outcomes

  1. 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

    Time frame: 30 days

Secondary outcomes

  1. 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

    Time frame: 30 Days

Sponsors and collaborators

Lead sponsor

NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
First posted
Apr 4, 2008
Registry last updated
Apr 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.