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Inhaled Treprostinil for PAH: Open-label Extension (INTREPID - OL)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01557660
First received: March 14, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose
Open-label extension of RIN-PH-302.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: inhaled treprostinil Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Long term safety of inhaled treprostinil [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • Six-minute walk distance [ Time Frame: up to 5 years ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled treprostinil Drug: inhaled treprostinil
0.6mg/mL inhalation solution, up to 12 breaths four times a day

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Participation and completion of all required visits for study RIN-PH-302.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01557660     History of Changes
Other Study ID Numbers: RIN-PH-303
Study First Received: March 14, 2012
Last Updated: March 23, 2012

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

ClinicalTrials.gov processed this record on July 26, 2017