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

Sponsor
NovaCardia, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00652782
Collaborator
Merck Sharp & Dohme LLC (Industry)
160
Enrollment
5
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Aug 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

rolofyline 2.5 mg IV QD

Drug: rolofyline
rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
Other Names:
  • MK7418

    		•
    Experimental: 2

    rolofyline 15 mg IV QD

    Drug: rolofyline
    rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
    Other Names:
  • MK7418

    		•
    Experimental: 3

    rolofyline 30 mg IV QD

    Drug: rolofyline
    rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
    Other Names:
  • MK7418

    		•
    Experimental: 4

    rolofyline 60 mg IV QD

    Drug: rolofyline
    rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
    Other Names:
  • MK7418

    		•
    Placebo Comparator: 5

    placebo for rolofyline IV QD

    Drug: Comparator Placebo (unspecified)
    Matching placebo for rolofyline IV QD; 3 days

    Outcome Measures

    Primary Outcome Measures

    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 [30 days]

    Secondary Outcome Measures

    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 [30 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • NovaCardia, Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00652782
    Other Study ID Numbers:
    • 2007_806
    • MK7418-201
    First Posted:
    Apr 4, 2008
    Last Update Posted:
    Apr 4, 2008
    Last Verified:
    Apr 1, 2008
    Additional relevant MeSH terms:
    Renal Insufficiency
    Heart Failure
    Rolofylline

    Study Results

    No Results Posted as of Apr 4, 2008