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NCT03387215 · ClinicalTrials.gov registry record · Phase 1
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
A Phase 1 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03387215: Completed Phase 1 study, sponsored by Intra-Cellular Therapies.
NCT03387215 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387215, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Cardiac systolic and diastolic function
Interventions
- OTHER Placebo
- DRUG ITI-214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2020-03-16 |
| Phase | Phase 1 |
What the finished NCT03387215 record still lists
NCT03387215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03387215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03387215 about?
NCT03387215 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure". 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.
What is the current status of trial NCT03387215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-07-10. Estimated completion is 2020-03-16.
What interventions are being tested in trial NCT03387215?
The interventions under investigation include: Placebo (OTHER), ITI-214 (DRUG).
Who is sponsoring clinical trial NCT03387215?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03387215's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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