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Trial record 1 of 1 for:    ITI-214 | Heart Failure
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Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT03387215
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Drug: ITI-214 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 10 mg ITI-214
Single oral dose
Drug: ITI-214
Oral

Experimental: 30 mg ITI-214
Single oral dose
Drug: ITI-214
Oral

Experimental: 75 mg - 150 mg ITI-214
Single oral dose
Drug: ITI-214
Oral

Placebo Comparator: Placebo
Single oral dose
Other: Placebo
Oral




Primary Outcome Measures :
  1. Echocardiogram with Doppler imaging and hemodynamic monitoring [ Time Frame: 2 hours ]
    Cardiac systolic and diastolic function


Secondary Outcome Measures :
  1. 12-lead electrocardiogram (ECG) [ Time Frame: 2 hours ]
    Safety and tolerability

  2. Hemodynamic monitoring [ Time Frame: 5-6 hours ]
    Cardiac systolic and diastolic function

  3. Number of patients with treatment-emergent adverse events [ Time Frame: 5 days ]
    Safety and tolerability


Other Outcome Measures:
  1. Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers [ Time Frame: 2 hours ]
    Pharmacodynamics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387215


Contacts
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Contact: Kimberly Vanover, PhD 646-440-9333 itciclinicaltrials@intracellulartherapies.com

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Nisha Gilotra, MD         
United States, North Carolina
Duke Clinical Research Institute Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.

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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT03387215     History of Changes
Other Study ID Numbers: ITI-214-104
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases