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

Phase 2

Completed

• Conditions: Congestive Heart Failure; Renal Impairment
• Interventions: Drug: rolofyline; Drug: Comparator Placebo (unspecified)

• Registration Number: NCT00652782
• Lead Sponsor: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-08
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Last Update Submitted: 2008-04-01
• Study First Posted: 2008-04-04
• Last Update Posted: 2008-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	rolofyline	rolofyline 2.5 mg IV QD
2	rolofyline	rolofyline 15 mg IV QD
3	rolofyline	rolofyline 30 mg IV QD
4	rolofyline	rolofyline 60 mg IV QD
5	Comparator Placebo (unspecified)	placebo for rolofyline IV QD

Primary Outcome Measures

Name	Time	Method
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	30 days

Secondary Outcome Measures

Name	Time	Method
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	30 Days