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This study has been withdrawn prior to enrollment.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

September 25, 2008
January 29, 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Mexico
 
NCT00760916
TDE-PH-303
No
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