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)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00760916
• Date of registration: 25/09/2008
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: 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)
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00760916
• 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
• Phase: Phase 3

Countries of recruitment

Australia, Mexico, United States

Contacts

• Name: Kevin Laliberte, PharmD
• Affiliation: United Therapeutics

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: UT-15C 5 mg

Drug: UT-15C 1 mg

Drug: Placebo

Drug: UT-15C 0.25 mg

Primary Outcome(s)

Change in six-minute walk distance from Baseline to Week 12 [Time Frame: 12 weeks]

Secondary Outcome(s)

Borg Dyspnea Score [Time Frame: 12 weeks]

Trough Borg Dyspnea Score [Time Frame: 12 weeks]

Clinical Worsening Assessment [Time Frame: 12 weeks]

Electrocardiogram findings [Time Frame: 12 weeks]

Optional hemodynamic parameters [Time Frame: 12 weeks]

Dyspnea Fatigue Index [Time Frame: 12 weeks]

Pro-B-type natriuretic peptide (Pro-BNP) [Time Frame: 12 weeks]

Adverse events [Time Frame: 12 weeks]

Clinical Laboratory parameters [Time Frame: 12 weeks]

World Health Organization (WHO) Functional Class [Time Frame: 12 weeks]

Trough 6-Minute Walk Distance [Time Frame: 12 weeks]

Symptoms of PAH [Time Frame: 12 weeks]

Secondary ID(s)

TDE-PH-303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors