A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension (FREEDOM-C2)

This study is ongoing, but not recruiting participants.

First Received on April 23, 2009. Last Updated on May 5, 2011 History of Changes

Sponsor:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00887978

Purpose

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: UT-15C	Phase 3

Study Type:

Interventional

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Treprostinil Treprostinil sodium

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Change in 6-minute walk distance from Baseline to Week 16

Secondary Outcome Measures:

Borg Dyspnea Score
Clinical Worsening Assessment
Dyspnea Fatigue Index
Symptoms of PAH
World Health Organization (WHO) Functional Class
Clinical laboratory parameters [ Designated as safety issue: Yes ]
Electrocardiogram findings [ Designated as safety issue: Yes ]
Adverse Events [ Designated as safety issue: Yes ]
N-terminal pro-BNP
Vital Signs [ Designated as safety issue: Yes ]
Biomarkers
Quality of Life

Study Start Date:	June 2009
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A subject is eligible for inclusion in this study if all of the following criteria apply:
Between 18 and 75 years of age, inclusive.
Body weight at least 40 kg (approximately 90 lbs.)
PAH that is either idiopathic/familial; associated with collagen vascular disease; associated with HIV.
Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Reliable and cooperative with protocol requirements.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887978

Show 71 Study Locations

Sponsors and Collaborators

United Therapeutics

More Information

No publications provided

Responsible Party:	C. Shane McSwain, MHSc / Manager Clinical Operations, United Therapeutics
ClinicalTrials.gov Identifier:	NCT00887978 History of Changes
Other Study ID Numbers:	TDE-PH-308
Study First Received:	April 23, 2009
Last Updated:	May 5, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012