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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01557647
First Posted: March 19, 2012
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
  Purpose
To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Inhaled treprostinil Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Six-minute walk test [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Time to clinical worsening [ Time Frame: 1 day to 2.5 years. ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled treprostinil Drug: Inhaled treprostinil
0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
Placebo Comparator: placebo Drug: Placebo
placebo inhalation solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01557647     History of Changes
Other Study ID Numbers: RIN-PH-302
First Submitted: March 14, 2012
First Posted: March 19, 2012
Last Update Posted: March 26, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents