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

NCT00652782 | Completed Phase 2

• 2 other identifiers: 2007_806MK7418-201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congestive Heart Failure; Renal Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (5)

1

EXPERIMENTAL

rolofyline 2.5 mg IV QD

Drug: rolofyline

2

EXPERIMENTAL

rolofyline 15 mg IV QD

Drug: rolofyline

3

EXPERIMENTAL

rolofyline 30 mg IV QD

Drug: rolofyline

4

EXPERIMENTAL

rolofyline 60 mg IV QD

Drug: rolofyline

5

PLACEBO COMPARATOR

placebo for rolofyline IV QD

Drug: Comparator Placebo (unspecified)

Interventions

rolofyline DRUG

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

Also known as: MK7418

1; 2; 3; 4

Comparator Placebo (unspecified) DRUG

Matching placebo for rolofyline IV QD; 3 days

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Interventions

rolofylline

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: December 1, 2004
• Primary Completion: August 1, 2005
• Last Updated: April 4, 2008

Record last verified: 2008-04