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

Congestive Heart Failure Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of The Effects of MK7418, Both as Monotherapy and in Combination With Furosemide, On Diuresis and Renal Function in Patients With Congestive Heart Failure (CHF) And Renal Impairment Treated With Oral Loop Diuretics Who Require Hospitalization For Fluid Overload

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652782
• Other study ID #: 2007_806
• Secondary ID: MK7418-201
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2008
• Last updated: April 1, 2008
• Start date: December 2004

Study information

• Verified date: April 2008
• Source: NovaCardia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• rolofyline
rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
• Comparator Placebo (unspecified)
Matching placebo for rolofyline IV QD; 3 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NovaCardia, Inc.	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No