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

NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 2

Conditions: Renal Impairment; Congestive Heart Failure

Treatments: Drug: rolofyline; Drug: Comparator Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652782

2007_806

MK7418-201

Details and patient eligibility

About

A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

rolofyline 2.5 mg IV QD

Treatment:

Drug: rolofyline

2

Experimental group

Description:

rolofyline 15 mg IV QD

Treatment:

Drug: rolofyline

3

Experimental group

Description:

rolofyline 30 mg IV QD

Treatment:

Drug: rolofyline

4

Experimental group

Description:

rolofyline 60 mg IV QD

Treatment:

Drug: rolofyline

5

Placebo Comparator group

Description:

placebo for rolofyline IV QD

Treatment:

Drug: Comparator Placebo (unspecified)