An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01027949
First received: December 4, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

This study provides UT-15C (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed the TDE-PH-301, TDE-PH-302 or TDE-PH-308 studies. The purpose of this study is to assess the long term safety of UT-15C and to assess the effects of continued treatment with UT-15C on exercise capacity after one year of treatment.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Treprostinil diethanolamine
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Six-Minute Walk Distance [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Long-term safety as assessed by clinical laboratories [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Long-term safety as assessed by adverse events [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: May 2006
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label UT-15C Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of TDE-PH-301, TDE-PH-302 or TDE-PH-308

Exclusion Criteria:

  • Premature discontinuation of TDE-PH-301, TDE-PH-302 or TDE-PH-308
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027949

  Show 109 Study Locations
Sponsors and Collaborators
United Therapeutics
Investigators
Study Director: Kevin Laliberte, PharmD United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01027949     History of Changes
Other Study ID Numbers: TDE-PH-304
Study First Received: December 4, 2009
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014