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

Pulmonary Hypertension Clinical Trial

Official title:

FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00760916
• Other study ID #: TDE-PH-303
• Status: Withdrawn
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: January 29, 2013
• Start date: December 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2013
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 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. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.

Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Description:

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)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 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. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.

Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Between 18 and 70 years of age, inclusive

• Body weight at least 50 kilograms

• 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 or not currently receiving approved PAH therapy.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• UT-15C 1 mg
UT-15C 1 mg
• UT-15C 0.25 mg
UT-15C 0.25 mg
• UT-15C 5 mg
UT-15C 5 mg
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Prince Charles Hospital	Brisbane
Australia	The Alfred Hospital	Melbourne
Australia	St. Vincent's Hospital	Sydney	New South Wales
Mexico	Instituto Nacional de Cardiologia	Mexico City	DF
Mexico	Unidad de Investigacion Clinica en Medicina (UDICEM)	Monterrey
United States	Pulmonary Hypertension Clinic	Aurora	Colorado
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Iowa Health Care	Iowa City	Iowa
United States	Kansas University Medical Center	Kansas City	Kansas
United States	West Los Angeles VA Healthcare Center	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Lagacy Clinic Northwest	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Center	Sacramento	California
United States	Washington University Hospital	St. Louis	Missouri
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Australia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six-minute walk distance from Baseline to Week 12		12 weeks	No
Secondary	Borg Dyspnea Score		12 weeks	No
Secondary	Clinical Worsening Assessment		12 weeks	Yes
Secondary	Dyspnea Fatigue Index		12 weeks	No
Secondary	Symptoms of PAH		12 weeks	No
Secondary	World Health Organization (WHO) Functional Class		12 weeks	No
Secondary	Trough 6-Minute Walk Distance		12 weeks	No
Secondary	Trough Borg Dyspnea Score		12 weeks	No
Secondary	Pro-B-type natriuretic peptide (Pro-BNP)		12 weeks	No
Secondary	Optional hemodynamic parameters		12 weeks	No
Secondary	Adverse events		12 weeks	Yes
Secondary	Clinical Laboratory parameters		12 weeks	Yes
Secondary	Electrocardiogram findings		12 weeks	Yes