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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 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 36 participants.

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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.

Interventions

  • OTHER Placebo
  • DRUG ITI-214

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2018-07-10
Est. Completion 2020-03-16
Phase Phase 1

Sponsor

Intra-Cellular Therapies

37 total trials

What the Registry Record Tells You About NCT03387215

The ClinicalTrials.gov registry entry for NCT03387215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03387215 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.