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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.
ClinicalTrials.gov Identifier:
NCT00652782
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 1, 2008
April 1, 2008
December 2004
August 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Renal Impairment
  • Drug: rolofyline
    rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
    Other Name: MK7418
  • Drug: Comparator Placebo (unspecified)
    Matching placebo for rolofyline IV QD; 3 days
  • Experimental: 1
    rolofyline 2.5 mg IV QD
    Intervention: Drug: rolofyline
  • Experimental: 2
    rolofyline 15 mg IV QD
    Intervention: Drug: rolofyline
  • Experimental: 3
    rolofyline 30 mg IV QD
    Intervention: Drug: rolofyline
  • Experimental: 4
    rolofyline 60 mg IV QD
    Intervention: Drug: rolofyline
  • Placebo Comparator: 5
    placebo for rolofyline IV QD
    Intervention: Drug: Comparator Placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Not Provided
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00652782
2007_806, MK7418-201
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
NovaCardia, Inc.
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
NovaCardia, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP