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JNJ-39588146 5 ng/kg/min · 1 trial · 1 indication
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...
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JNJ-39588146 is an investigational small molecule being studied for the treatment of heart failure. It is administered as an intravenous solution and is currently in Phase 2 clinical development. The drug is being evaluated for its safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with heart failure.
JNJ-39588146 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's potential in treating heart failure.
JNJ-39588146 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for its safety and efficacy in patients with heart failure.
JNJ-39588146 has one completed Phase 2 clinical trial registered under NCT01120210. The study investigated the safety, tolerability, pharmacodynamics, and pharmacokinetics of an intravenous solution of JNJ-39588146 or placebo in patients with heart failure. The trial enrolled 62 participants across Belgium, Germany, Poland, and Romania.
No alternative names for JNJ-39588146 have been disclosed. The drug is identified solely by its development code JNJ-39588146 in clinical trial registrations and related research documentation.