CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
JNJ-39588146 5 ng/kg/min +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01120210
NCT01120210Phase 2Completed
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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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted May 10, 2010·Updated Jul 19, 2013

In Brief

A Phase 2 clinical trial evaluating JNJ-39588146 5 ng/kg/min, JNJ-39588146 15 ng/kg/min, and 3 other interventions for Heart Failure. Completed, enrolled 62 participants across 9 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesBelgium, Germany, Poland, Romania
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2010
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago

Interventions

JNJ-39588146 5 ng/kg/mindrug

1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1

JNJ-39588146 15 ng/kg/mindrug

1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1

JNJ-39588146 30 ng/kg/mindrug

1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1

Placebodrug

1-hour infusion of matching placebo on Day 1

JNJ-39588146 5, 15, or 30 ng/kg/mindrug

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.