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This study has been withdrawn prior to enrollment.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
  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:


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
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: NCT00760916

  Show 31 Study Locations
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
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Phosphodiesterase 5 Inhibitors
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014