Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients (NCT00652782) | Clinical Trial Compass
CompletedPhase 2
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
160 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
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
Timeframe: 30 days
Trial details
NCT IDNCT00652782
SponsorNovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)