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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

United Therapeutics

ClinicalTrials.gov Identifier:

NCT01557647

First received: March 14, 2012

Last updated: March 23, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2012
Last Updated Date	March 23, 2012
Start Date ^ICMJE	June 2012
Estimated Primary Completion Date	December 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 15, 2012)	Six-minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01557647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 15, 2012)	Time to clinical worsening [ Time Frame: 1 day to 2.5 years. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Inhaled Treprostinil in Patients With PAH
Official Title ^ICMJE	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.
Brief Summary	To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Arterial Hypertension
Intervention ^ICMJE	Drug: Inhaled treprostinil 0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID. Drug: Placebo placebo inhalation solution
Study Arm (s)	Experimental: inhaled treprostinil Intervention: Drug: Inhaled treprostinil Placebo Comparator: placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	June 2016
Estimated Primary Completion Date	December 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01557647
Other Study ID Numbers ^ICMJE	RIN-PH-302
Has Data Monitoring Committee	Yes
Responsible Party	United Therapeutics
Study Sponsor ^ICMJE	United Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	United Therapeutics
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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