Status:
COMPLETED
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- NYHA class II-III heart failure
- Ejection fraction equal to or below 35%
- On stable heart failure drug treatment
Exclusion
- Considered medically inappropriate for study participation
Key Trial Info
Start Date :
July 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03387215
Start Date
July 10 2018
End Date
March 16 2020
Last Update
December 24 2020
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
2
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710