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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00760916




Registration number
NCT00760916
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
30/01/2013

Titles & IDs
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
Secondary ID [1] 0 0
TDE-PH-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UT-15C 1 mg
Treatment: Drugs - UT-15C 0.25 mg
Treatment: Drugs - UT-15C 5 mg
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - placebo

Active Comparator: UT-15C 0.25 mg - UT-15C 0.25 mg

Active Comparator: UT-15C 1 mg - UT-15C 1 mg

Active Comparator: UT-15C 5 mg - UT-15C 5 mg


Treatment: Drugs: UT-15C 1 mg
UT-15C 1 mg

Treatment: Drugs: UT-15C 0.25 mg
UT-15C 0.25 mg

Treatment: Drugs: UT-15C 5 mg
UT-15C 5 mg

Treatment: Drugs: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in six-minute walk distance from Baseline to Week 12
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Borg Dyspnea Score
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Clinical Worsening Assessment
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Dyspnea Fatigue Index
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Symptoms of PAH
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
World Health Organization (WHO) Functional Class
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Trough 6-Minute Walk Distance
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Trough Borg Dyspnea Score
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Pro-B-type natriuretic peptide (Pro-BNP)
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Optional hemodynamic parameters
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Adverse events
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Clinical Laboratory parameters
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Electrocardiogram findings
Timepoint [12] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Mexico
State/province [18] 0 0
DF
Country [19] 0 0
Mexico
State/province [19] 0 0
Monterrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00760916
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kevin Laliberte, PharmD
Address 0 0
United Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00760916