Phase 2
Completed N=62
A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure
Source: ClinicalTrials.gov NCT01120210 ↗Enrolled (actual)
62
Serious AEs
12.9%
Results posted
Jun 2013
Primary outcomePrimary: Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI) — -0.03; 0.24; -0.15; 0.18 L/min/m2 — p=0.0595
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI) |
-0.03; 0.24; -0.15; 0.18; -0.05; 0.52 | 0.0595 |
| PRIMARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP) |
-0.75; -0.84; 0.15; -1.20; 0.05; -2.53 | 0.4729 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR) |
3.02; 2.69; 3.72; 4.96; 3.07; 5.23 | 0.7682 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP) |
0.15; -0.53; 6.94; 4.94; 6.32; 2.55 | 0.8030 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP) |
-0.43; -3.78; 1.83; -3.72; 3.05; -4.03 | 0.1561 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV) |
-15.51; -15.28 | 0.9769 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV) |
-13.91; -11.93 | 0.8297 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF) |
3.61; 3.92 | 0.8650 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS) |
0.22; 1.17 | 0.3748 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV) |
-1.34; 5.75; -4.33; 4.45; -0.62; 13.54 | 0.2123 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP) |
2.69; 1.32; 0.51; -0.48; -0.79; 0.24 | 0.4841 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP) |
-0.99; -0.29; -0.83; -1.17; -0.72; -1.46 | 0.6304 |
| SECONDARY Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR) |
67.41; -196.95; 321.97; -61.36; 281.79; -245.98 | 0.0510 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01120210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.