FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) - Full Text View

Sponsor:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00325442

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. One optional substudy is also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who complete all assessments for 16-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Oral treprostinil (UT-15C) Sustained Release Tablets	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: U 62840 Remodulin

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
World Health Organization Functional Classification for PAH
Symptoms of PAH
Adverse events
Clinical laboratory parameters
Electrocardiogram findings

Estimated Enrollment:	300
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 12 and 70 years of age, inclusive.
Body weight at least 45 kg (approximately 100 pounds).
PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); 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.

Exclusion Criteria:

Nursing or pregnant.
Received a prostacyclin within the past 30 days.
PAH due to conditions other than noted in the above inclusion criteria.
History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
Use of an investigational drug within 30 days of Baseline.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325442

Show 69 Study Locations

Sponsors and Collaborators

United Therapeutics

More Information

No publications provided

Study ID Numbers:	TDE-PH-301
Study First Received:	May 11, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00325442 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

Pulmonary Arterial Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases
Treprostinil
Vascular Diseases

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 30, 2009