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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00760916
First Posted: September 26, 2008
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United Therapeutics
September 25, 2008
September 26, 2008
January 30, 2013
December 2008
January 2009   (Final data collection date for primary outcome measure)
Change in six-minute walk distance from Baseline to Week 12 [ Time Frame: 12 weeks ]
Change in 6-Minute Walk distance from Baseline to Week 12 in subjects with PAH
Complete list of historical versions of study NCT00760916 on ClinicalTrials.gov Archive Site
  • Borg Dyspnea Score [ Time Frame: 12 weeks ]
  • Clinical Worsening Assessment [ Time Frame: 12 weeks ]
  • Dyspnea Fatigue Index [ Time Frame: 12 weeks ]
  • Symptoms of PAH [ Time Frame: 12 weeks ]
  • World Health Organization (WHO) Functional Class [ Time Frame: 12 weeks ]
  • Trough 6-Minute Walk Distance [ Time Frame: 12 weeks ]
  • Trough Borg Dyspnea Score [ Time Frame: 12 weeks ]
  • Pro-B-type natriuretic peptide (Pro-BNP) [ Time Frame: 12 weeks ]
  • Optional hemodynamic parameters [ Time Frame: 12 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
  • Clinical Laboratory parameters [ Time Frame: 12 weeks ]
  • Electrocardiogram findings [ Time Frame: 12 weeks ]
  • Borg Dyspnea Score
  • Clinical Worsening Assessment
  • Dyspnea Fatigue Index
  • Symptoms of PAH
  • World Health Organization (WHO) Functional Class
  • Trough 6-Minute Walk Distance
  • Trough Borg Dyspnea Score
  • Pro-B-type natriuetic peptide (Pro-BNP)
  • Optional hemodynamic parameters
  • Adverse events
  • Clinical Laboratory parameters
  • Electrocardiogram findings
Not Provided
Not Provided
 
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)
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

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).

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: UT-15C 1 mg
    UT-15C 1 mg
  • Drug: UT-15C 0.25 mg
    UT-15C 0.25 mg
  • Drug: UT-15C 5 mg
    UT-15C 5 mg
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
  • Active Comparator: UT-15C 0.25 mg
    UT-15C 0.25 mg
    Intervention: Drug: UT-15C 0.25 mg
  • Active Comparator: UT-15C 1 mg
    UT-15C 1 mg
    Intervention: Drug: UT-15C 1 mg
  • Active Comparator: UT-15C 5 mg
    UT-15C 5 mg
    Intervention: Drug: UT-15C 5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Mexico,   United States
 
 
NCT00760916
TDE-PH-303
No
Not Provided
Not Provided
Brett Goetz, Associate Manager, Clinical Operations, United Therapeutics
United Therapeutics
Not Provided
Study Director: Kevin Laliberte, PharmD United Therapeutics
United Therapeutics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP