Status:
COMPLETED
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
Lead Sponsor:
NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Congestive Heart Failure
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00652782
Start Date
December 1 2004
Last Update
April 4 2008
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