Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
- Registration Number
- NCT03387215
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- NYHA class II-III heart failure
- Ejection fraction equal to or below 35%
- On stable heart failure drug treatment
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Exclusion Criteria
- Considered medically inappropriate for study participation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 10 mg ITI-214 ITI-214 Single oral dose 30 mg ITI-214 ITI-214 Single oral dose 75 mg - 150 mg ITI-214 ITI-214 Single oral dose Placebo Placebo Single oral dose
- Primary Outcome Measures
Name Time Method Echocardiogram with Doppler imaging and hemodynamic monitoring 2 hours Cardiac systolic and diastolic function
- Secondary Outcome Measures
Name Time Method 12-lead electrocardiogram (ECG) 2 hours Safety and tolerability
Hemodynamic monitoring 5-6 hours Cardiac systolic and diastolic function
Number of patients with treatment-emergent adverse events 5 days Safety and tolerability
Trial Locations
- Locations (2)
Duke Clinical Research Institute
🇺🇸Durham, North Carolina, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States