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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652782
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
NovaCardia, Inc.

Study Description
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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
Congestive Heart Failure Renal Impairment Drug: rolofyline Drug: Comparator Placebo (unspecified) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Primary Completion Date : August 2005

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Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: MK7418
Placebo Comparator: 5
placebo for rolofyline IV QD
 Drug: Comparator Placebo (unspecified)
Matching placebo for rolofyline IV QD; 3 days


Outcome Measures
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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 [ Time Frame: 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 [ Time Frame: 30 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652782


Sponsors and Collaborators
NovaCardia, Inc.
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00652782    
Other Study ID Numbers: 2007_806
MK7418-201
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Renal Insufficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
 Urologic Diseases
Rolofylline
Diuretics
Natriuretic Agents
Physiological Effects of Drugs