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

Heart Failure, Systolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387215
• Other study ID #: ITI-214-104
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 10, 2018
• Est. completion date: March 16, 2020

Study information

• Verified date: December 2020
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• ITI-214
Oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers	Pharmacodynamics	2 hours
Primary	Echocardiogram with Doppler imaging and hemodynamic monitoring	Cardiac systolic and diastolic function	2 hours
Secondary	12-lead electrocardiogram (ECG)	Safety and tolerability	2 hours
Secondary	Hemodynamic monitoring	Cardiac systolic and diastolic function	5-6 hours
Secondary	Number of patients with treatment-emergent adverse events	Safety and tolerability	5 days