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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by NovaCardia, Inc.:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2004
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652782

Sponsors and Collaborators
NovaCardia, Inc.
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00652782     History of Changes
Other Study ID Numbers: 2007_806, MK7418-201
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014