Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Systolic

In brief

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.

Key facts

Study ID

NCT03387215

Run by

Intra-Cellular Therapies, Inc.

People needed

36

Starts

2018-07-10

Expected to finish

2020-03-16

Last updated by the study team

2020-12-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NYHA class II-III heart failure
• Ejection fraction equal to or below 35%
• On stable heart failure drug treatment

You may not qualify if…

• Considered medically inappropriate for study participation

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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