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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)

This study has been withdrawn prior to enrollment.
(Study stopped prior to subject enrollment.)
Sponsor:
Information provided by:
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00760916
First received: September 25, 2008
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  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)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).


Condition Intervention Phase
Pulmonary Hypertension
 Drug: UT-15C 1 mg
Drug: UT-15C 0.25 mg
Drug: UT-15C 5 mg
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Change in six-minute walk distance from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Borg Dyspnea Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Worsening Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Dyspnea Fatigue Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Symptoms of PAH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • World Health Organization (WHO) Functional Class [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Trough 6-Minute Walk Distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Trough Borg Dyspnea Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pro-B-type natriuretic peptide (Pro-BNP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Optional hemodynamic parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo
 Drug: Placebo
Placebo
Active Comparator: UT-15C 0.25 mg
UT-15C 0.25 mg
 Drug: UT-15C 0.25 mg
UT-15C 0.25 mg
Active Comparator: UT-15C 1 mg
UT-15C 1 mg
 Drug: UT-15C 1 mg
UT-15C 1 mg
Active Comparator: UT-15C 5 mg
UT-15C 5 mg
 Drug: UT-15C 5 mg
UT-15C 5 mg

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760916

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, California
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
UC Davis Medical Center
Sacramento, California, United States, 95817
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Pulmonary Hypertension Clinic
Aurora, Colorado, United States, 80045
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Missouri
Washington University Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Weill Cornell Medical Center
New York, New York, United States, 10021
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
Rochester, New York, United States, 14643
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Lagacy Clinic Northwest
Portland, Oregon, United States, 97210
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75235
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157-7000
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Australia, New South Wales
St. Vincent's Hospital
Sydney, New South Wales, Australia
Australia
Prince Charles Hospital
Brisbane, Australia
The Alfred Hospital
Melbourne, Australia
Mexico
Instituto Nacional de Cardiologia
Mexico City, DF, Mexico, 14080
Unidad de Investigacion Clinica en Medicina (UDICEM)
Monterrey, Mexico
Sponsors and Collaborators
United Therapeutics
Investigators
Study Director: Kevin Laliberte, PharmD United Therapeutics
  More Information

No publications provided

Responsible Party: Brett Goetz, Associate Manager, Clinical Operations, United Therapeutics
ClinicalTrials.gov Identifier: NCT00760916     History of Changes
Other Study ID Numbers: TDE-PH-303
Study First Received: September 25, 2008
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Phosphodiesterase 5 Inhibitors
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013