Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NovaCardia, Inc.
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Rolofylline
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