INTREPID: Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

• Sponsor: United Therapeutics (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01557647
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled treprostinil; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• 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.
• Study Start Date: Jun 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Six-minute walk test [6 months]

Secondary Outcome Measures

1. Time to clinical worsening [1 day to 2.5 years.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• United Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: United Therapeutics
• ClinicalTrials.gov Identifier: NCT01557647
• Other Study ID Numbers: RIN-PH-302
• First Posted: Mar 19, 2012
• Last Update Posted: Mar 26, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Treprostinil

Study Results

No Results Posted as of Mar 26, 2012