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

Primary Purpose

Congestive Heart Failure, Renal Impairment

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rolofyline
Comparator Placebo (unspecified)
Sponsored by
NovaCardia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    rolofyline 2.5 mg IV QD

    rolofyline 15 mg IV QD

    rolofyline 30 mg IV QD

    rolofyline 60 mg IV QD

    placebo for rolofyline IV QD

    Outcomes

    Primary Outcome 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

    Secondary Outcome 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

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    April 1, 2008
    Sponsor
    NovaCardia, Inc.
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00652782
    Brief Title
    Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    NovaCardia, Inc.
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congestive Heart Failure, Renal Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    rolofyline 2.5 mg IV QD
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    rolofyline 15 mg IV QD
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    rolofyline 30 mg IV QD
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    rolofyline 60 mg IV QD
    Arm Title
    5
    Arm Type
    Placebo Comparator
    Arm Description
    placebo for rolofyline IV QD
    Intervention Type
    Drug
    Intervention Name(s)
    rolofyline
    Other Intervention Name(s)
    MK7418
    Intervention Description
    rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator Placebo (unspecified)
    Intervention Description
    Matching placebo for rolofyline IV QD; 3 days
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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