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A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01120210
First received: May 6, 2010
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of an intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with heart failure. The highest tolerated dose received during the first 3 hours of the study will be administered to some patients for an additional 18 hours. There will be up to 3 doses given throughout the administration period over a total of up to 21 hours.


Condition Intervention Phase
Heart Failure
 Drug: JNJ-39588146 5 ng/kg/min
Drug: JNJ-39588146 15 ng/kg/min
Drug: JNJ-39588146 30 ng/kg/min
Drug: Placebo
Drug: JNJ-39588146 5, 15, or 30 ng/kg/min
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JNJ-39588146 in Subjects With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Post-baseline change in cardiac index (CI) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in pulmonary capillary wedge pressure (PCWP) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-baseline change in Heart Rate (HR) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in systolic blood pressure (SBP) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in diastolic blood pressure (DBP) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in left ventricular end systolic volume (LVESV) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in left ventricular end diastolic volume (LVEDV) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in left ventricular ejection fraction (LVEF) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in fractional shortening (FS) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in stroke volume (SV) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in pulmonary arterial systolic pressure (PASP) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in pulmonary arterial diastolic pressure (PADP) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]
  • Post-baseline change in calculated systemic vascular resistance (SVR) [ Time Frame: Baseline up through 3 hours post infusion initiation ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 (Main Study)
3 consecutive 1-hour infusions of JNJ-39588146 5, 15, or 30 ng/kg/min or matching placebo
 Drug: JNJ-39588146 5 ng/kg/min
1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1
Drug: JNJ-39588146 15 ng/kg/min
1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1
Drug: JNJ-39588146 30 ng/kg/min
1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1
Drug: Placebo
1-hour infusion of matching placebo on Day 1
Experimental: Part 2 (Extended Infusion Sub-Study)
1 18-hr infusion of JNJ-39588146 of the highest tolerated dose from Part 1 of the study or matching placebo
 Drug: Placebo
1-hour infusion of matching placebo on Day 1
Drug: JNJ-39588146 5, 15, or 30 ng/kg/min
18-hour infusion of JNJ-39588146 or matching placebo on Day 1 immediately folllowing the 3-hour infusion at a dose equal to the maximum dose tolerated by that patient during the 3-hour infusion in Part 1 of the study.

Detailed Description:

This study will assess the safety, tolerability, pharmacodynamics and pharmacokinetics of JNJ-39588146 or placebo (which looks like the drug being studied but has no active ingredients) in patients with heart failure. This study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by chance), double-blind (neither the physician nor patient knows the identity of the assigned drug) study of 3 intravenous doses of JNJ-39588146 or placebo administered in 1-hr intervals (for a total of 3 hours) in 60 patients with heart failure. Part 2 is an extended infusion of JNJ-39588146 and placebo that will administer the highest tolerated dose from Part 1 for an additional 18 hours. The entire duration of the infusion could be as long as 21 hours. There is a 1 in 4 chance of getting placebo. The participation period is a maximum of 42 days, including a screening visit, a 2-day in-clinic period and two follow-up visits. For both parts of the study, patients will have a cardiac catheter in place to monitor heart function. Safety evaluations, which will include ECG (electrocardiograph, measuring the electrical currents in the heart), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Part 1: Patients will receive an intravenous (IV) solution of three different doses of JNJ-39588146 or placebo administered over 1 hour periods for a total of 3 hours. Part 2: Patients participating in the sub study will continue receiving an IV solution for 18 more hours for a total of up to 21 hours of administration.

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have been diagnosed with heart failure
  • Women must be either postmenopausal or have been surgically sterilized at least 6 months ago
  • Males must be willing to use an acceptable birth control method for 3 months after the last dose of study medication.

Exclusion Criteria:

  • Patients must not have had an heart-assist device or heart transplant or be in imminent need of one
  • Patients must not have had an ischemic attack within the last 6 months or a heart attack within the last month
  • Patients must not have lung disease or congenital heart failure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120210

Locations
Belgium
Aalst, Belgium
B-1070 Bruxelles, Belgium
Genk, Belgium
Germany
Bad Nauheim, Germany
Hamburg, Germany
Poland
Warszawa, Poland
Wroclaw, Poland
Romania
Bucuresti, Romania
Tg. Mures, Romania
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01120210     History of Changes
Obsolete Identifiers: NCT01678768
Other Study ID Numbers: CR017116, 39588146AHF2001, 2009-013929-42
Study First Received: May 6, 2010
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Heart Failure
Cardiac Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013