Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients - Full Text View

Sponsor:	NovaCardia
Collaborator:	Merck
Information provided by:	NovaCardia
ClinicalTrials.gov Identifier:	NCT00652782

Purpose

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

Condition	Intervention	Phase
Congestive Heart Failure Renal Impairment	Drug: rolofyline Drug: Comparator Placebo (unspecified)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by NovaCardia:

Primary Outcome Measures:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	December 2004
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental rolofyline 2.5 mg IV QD	Drug: rolofyline rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
2: Experimental rolofyline 15 mg IV QD	Drug: rolofyline rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
3: Experimental rolofyline 30 mg IV QD	Drug: rolofyline rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
4: Experimental rolofyline 60 mg IV QD	Drug: rolofyline rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days
5: Placebo Comparator placebo for rolofyline IV QD	Drug: Comparator Placebo (unspecified) Matching placebo for rolofyline IV QD; 3 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652782

Sponsors and Collaborators

NovaCardia

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_806, MK7418-201
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00652782 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2009