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

• Status: Completed
• Trial end date: 2020-03-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.

Criteria

Inclusion Criteria:

• NYHA class II-III heart failure

• Ejection fraction equal to or below 35%

• On stable heart failure drug treatment

Exclusion Criteria:

• Considered medically inappropriate for study participation