Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
Information source: NovaCardia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure; Renal Impairment
Intervention: rolofyline (Drug); Comparator Placebo (unspecified) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: NovaCardia Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: April 1, 2008
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