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

Intra-Cellular Therapies, Inc.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure, Systolic

Interventions

ITI-214DRUG

Oral

PlaceboOTHER

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins University

Baltimore, Maryland, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Echocardiogram with Doppler imaging and hemodynamic monitoring

Cardiac systolic and diastolic function

Time frame: 2 hours

Secondary Outcomes

12-lead electrocardiogram (ECG)

Safety and tolerability

Time frame: 2 hours

Hemodynamic monitoring

Cardiac systolic and diastolic function

Time frame: 5-6 hours

Number of patients with treatment-emergent adverse events

Safety and tolerability

Time frame: 5 days

Data from ClinicalTrials.gov

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