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

NCT ID: NCT00652782

Last Updated: 2008-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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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

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Conditions

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Congestive Heart Failure Renal Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

rolofyline 2.5 mg IV QD

Group Type EXPERIMENTAL

rolofyline

Intervention Type DRUG

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

2

rolofyline 15 mg IV QD

Group Type EXPERIMENTAL

rolofyline

Intervention Type DRUG

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

3

rolofyline 30 mg IV QD

Group Type EXPERIMENTAL

rolofyline

Intervention Type DRUG

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

4

rolofyline 60 mg IV QD

Group Type EXPERIMENTAL

rolofyline

Intervention Type DRUG

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

5

placebo for rolofyline IV QD

Group Type PLACEBO_COMPARATOR

Comparator Placebo (unspecified)

Intervention Type DRUG

Matching placebo for rolofyline IV QD; 3 days

Interventions

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rolofyline

rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days

Intervention Type DRUG

Comparator Placebo (unspecified)

Matching placebo for rolofyline IV QD; 3 days

Intervention Type DRUG

Other Intervention Names

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MK7418

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Merck & Co., Inc.

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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MK7418-201

Identifier Type: -

Identifier Source: secondary_id

2007_806

Identifier Type: -

Identifier Source: org_study_id