Official 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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2005

Intervention(s) in this Clinical Trial

• Drug: rolofyline
  • rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
• Drug: Comparator Placebo (unspecified)
  • Matching placebo for rolofyline IV QD; 3 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • rolofyline 2.5 mg IV QD
• Experimental: 2
  • rolofyline 15 mg IV QD
• Experimental: 3
  • rolofyline 30 mg IV QD
• Experimental: 4
  • rolofyline 60 mg IV QD
• Placebo Comparator: 5
  • placebo for rolofyline IV QD

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: NovaCardia

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652782

Study ID Number: 2007_806

ClinicalTrials.gov Identifier: NCT00652782

Health Authority: United States: Food and Drug Administration