A Phase 1/2 interventional study of ITI-214 and Placebo in Heart Failure, Systolic, sponsored by Intra-Cellular Therapies, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 1/2, Interventional, and Treatment
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 38th largest by enrollment of the 69 interventional ones that give a count, is one of 10 that started in 2018, is one of 4 in phase 1/2, and was the 31st registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
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24 of 83 have an industry lead sponsor. The 10 most frequent:
This study is registered under Intra-Cellular Therapies, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Johnson & Johnson has 4 studies filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
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Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single oral dose
Drug: ITI-214
Single oral dose
Drug: ITI-214
Single oral dose
Drug: ITI-214
Single oral dose
Other: Placebo
Oral
Oral
Echocardiogram with Doppler imaging and hemodynamic monitoring
Cardiac systolic and diastolic function
Time frame: 2 hours
12-lead electrocardiogram (ECG)
Safety and tolerability
Time frame: 2 hours
Hemodynamic monitoring
Cardiac systolic and diastolic function
Time frame: 5-6 hours
Number of patients with treatment-emergent adverse events
Safety and tolerability
Time frame: 5 days
Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers
Pharmacodynamics
Time frame: 2 hours
Ran from Jul 2018 to primary completion in Mar 2020, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ITI-214
Intra-Cellular Therapies, Inc. →