Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01120210 | A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure | PHASE2 | COMPLETED | 62 | — | — | Jun 1, 2010 | Sep 1, 2011 | Jul 19, 2013 | 9 | Belgium, Germany +2 |
The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors.
The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Main Study) | EXPERIMENTAL | 3 consecutive 1-hour infusions of JNJ-39588146 5, 15, or 30 ng/kg/min or matching placebo |
| Part 2 (Extended Infusion Sub-Study) | EXPERIMENTAL | 1 18-hr infusion of JNJ-39588146 of the highest tolerated dose from Part 1 of the study or matching placebo |
| Name | Type | Description |
|---|---|---|
| JNJ-39588146 5 ng/kg/min | DRUG | 1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1 |
| JNJ-39588146 15 ng/kg/min | DRUG | 1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1 |
| JNJ-39588146 30 ng/kg/min | DRUG | 1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1 |
| Placebo | DRUG | 1-hour infusion of matching placebo on Day 1 |
| JNJ-39588146 5, 15, or 30 ng/kg/min | DRUG | 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. |
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. Exclusio...