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

NCT03387215 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-12-24

No results posted yet for this study

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.

Conditions

  • Heart Failure, Systolic

Interventions

DRUG

ITI-214

Oral

OTHER

Placebo

Oral

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2020-03-16
Completion
2020-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387215 on ClinicalTrials.gov