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: May 10, 2016

Last verified: May 2016

History of Changes

Purpose

This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect 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:

Genetics Home Reference related topics: pulmonary arterial hypertension

Drug Information available for: Treprostinil Treprostinil sodium Treprostinil diolamine

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test [ Time Frame: Once, after one year of therapy with UT-15C SR. ] [ Designated as safety issue: No ]
Long-term safety as assessed by clinical laboratories [ Time Frame: Performed at each study scheduled visit ] [ Designated as safety issue: Yes ]
After one year exposure to UT-15C clinical laboratorial assessments will occur 1 time/year through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.
Long-term safety as assessed by adverse events [ Time Frame: Performed monthly during monthly telephone calls ] [ Designated as safety issue: Yes ]
Telephone calls will occur at a minimum 1 time/month through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.


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: Treprostinil diethanolamine (UT-15C) All open will receive active study drug	Drug: Treprostinil diethanolamine Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.

Detailed Description:

This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.

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


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:	May 10, 2016
Health Authority:	United States: Food and Drug Administration

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 September 26, 2016

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