Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
0
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/study/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/study/NCT00760916