Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

Phase 3

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Inhaled treprostinil; Drug: Placebo

• Registration Number: NCT01557647
• Lead Sponsor: United Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26
• Study Start: 2012-06
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inhaled treprostinil	Inhaled treprostinil	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Six-minute walk test	6 months

Secondary Outcome Measures

Name	Time	Method
Time to clinical worsening	1 day to 2.5 years.