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Safety and Efficacy of Inhaled Treprostinil in Patients With PAH (INTREPID)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Inhaled treprostinil
Placebo
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligible subjects must:

  • Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),
  • Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.
  • Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.
  • Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    inhaled treprostinil

    placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Six-minute walk test

    Secondary Outcome Measures

    Time to clinical worsening

    Full Information

    First Posted
    March 14, 2012
    Last Updated
    March 23, 2012
    Sponsor
    United Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01557647
    Brief Title
    Safety and Efficacy of Inhaled Treprostinil in Patients With PAH
    Acronym
    INTREPID
    Official Title
    Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    June 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    United Therapeutics

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Arterial Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    inhaled treprostinil
    Arm Type
    Experimental
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Inhaled treprostinil
    Intervention Description
    0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo inhalation solution
    Primary Outcome Measure Information:
    Title
    Six-minute walk test
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Time to clinical worsening
    Time Frame
    1 day to 2.5 years.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Eligible subjects must: Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed), Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use. Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening. Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.

    12. IPD Sharing Statement

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    Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

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