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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04084678




Registration number
NCT04084678
Ethics application status
Date submitted
6/09/2019
Date registered
10/09/2019
Date last updated
8/04/2021

Titles & IDs
Public title
A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy
Secondary ID [1] 0 0
ROR-PH-302
Universal Trial Number (UTN)
Trial acronym
CAPACITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PAH 0 0
Pulmonary Hypertension 0 0
Hypertension 0 0
Connective Tissue Disease 0 0
Familial Primary Pulmonary Hypertension 0 0
Vascular Diseases 0 0
Cardiovascular Diseases 0 0
Hypertension, Pulmonary 0 0
Lung Diseases 0 0
Respiratory Tract Disease 0 0
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ralinepag
Treatment: Drugs - Placebo

Experimental: Ralinepag - Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose (maximum dose of 1400 mcg)

Placebo Comparator: Placebo - Matching placebo tablets (oral)


Treatment: Drugs: Ralinepag
Oral ralinepag

Treatment: Drugs: Placebo
Matching oral tablets

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

Outcomes
Primary outcome [1] 0 0
Change from Baseline in peak VO2 assessed by CPET - Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [1] 0 0
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) - NT-proBNP was measured at Baseline (prior to starting study drug) and Weeks 4, 8, 12, 16, 20, 24 and 28
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [2] 0 0
Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope - VE/VCO2 slope (from CPET) was calculated at Baseline (prior to starting study drug) and Week 28
Timepoint [2] 0 0
Baseline to Week 28
Secondary outcome [3] 0 0
Change from Baseline in Health-related quality of life (HRQoL) measured by the Short Form Health Survey (SF-36) Scores - SF-36 was assessed at Baseline (prior to starting study drug) and Weeks 16 and 28. The SF-36 consisted of 36 questions in 8 health categories (Vitality, Physical Functioning, Bodily Pain, General Health Perception, Role Physical, Role Emotional, Social Functioning, and Mental Health). Responses to the questions were graded on a numerical scale, with 1 as the best score and higher numbers as worse scores. The raw scores from the subscales were converted and summed by the Investigator to a total score between 0 and 100 to measure functional health and well-being from the patient's point of view. The final score range was 0 (representing the lowest possible score; worst health state) to 100 (representing the highest possible score; best health state).
Timepoint [3] 0 0
Baseline to Week 28
Secondary outcome [4] 0 0
Time to First All-cause Non-elective Hospitalization - The time to first all-cause nonelective hospitalization during the study period will be assessed.
Timepoint [4] 0 0
Baseline to Week 28

Eligibility
Key inclusion criteria
1. At least 18 years of age

2. Primary diagnosis of PAH

3. Has had a diagnostic RHC performed within 1 year of Screening

4. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class
(FC) 2 to 3 symptoms

5. Must have initiated first PAH-specific oral therapy with an endothelin receptor
antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a sGC
stimulator within 9 months prior to Screening

6. Has a 6-minute walk distance (6MWD) of =150 meters at Screening

7. Has a VE/VCO2 slope =38 during the Screening CPET, as assessed by the CPET core lab

8. Has a peak VO2 of =10 to <18 mL·kg-1·min-1 during the Screening CPET, as assessed by
the CPET core lab
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has left ventricular disease

2. Current unstable angina

3. Symptomatic coronary disease and/or myocardial infarction within past 6 months

4. Current symptomatic aortic or mitral valve disease

5. Has evidence of more than mild lung disease on pulmonary function tests (PFTs)
performed within 1 year prior to, or during, Screening

6. Has evidence of thromboembolic disease

7. Current diagnosis of uncontrolled sleep apnea in the opinion of the Investigator

8. Requires use of supplemental oxygen during CPET

9. Respiratory exchange ratio (RER) <1.0 at Screening CPET as determined by the CPET core
laboratory

10. Acute non-cardiac disorder that may affect exercise performance or be aggravated by
exercise (eg, infection, renal failure, thyrotoxicosis)

11. Male subjects with a QTcF >450 msec and female subjects with QTcF >470 msec on
electrocardiogram (ECG)

12. Subject tests positive for amphetamine, cocaine, methamphetamine,
methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at
Screening, or has a recent history (6 months) of alcohol or drug abuse

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
Recruiting
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,QLD
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment hospital [2] 0 0
Westmead Hospital, Dept Respiratory and Sleep Medicine - Westmead
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Argentina
State/province [5] 0 0
Ciudad Autónoma de Bs. As.
Country [6] 0 0
Argentina
State/province [6] 0 0
Corrientes
Country [7] 0 0
Austria
State/province [7] 0 0
Linz
Country [8] 0 0
Austria
State/province [8] 0 0
Vienna
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Brazil
State/province [12] 0 0
Porto Alegre
Country [13] 0 0
Germany
State/province [13] 0 0
Baden-Wurttemberg
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Italy
State/province [15] 0 0
Rome
Country [16] 0 0
Poland
State/province [16] 0 0
Bialystok
Country [17] 0 0
Poland
State/province [17] 0 0
Otwock
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy
on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from
cardiopulmonary exercise testing (CPET) after 28 weeks of treatment
Trial website
https://clinicaltrials.gov/show/NCT04084678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
United Therapeutics Global Medical Information
Address 0 0
Country 0 0
Phone 0 0
919-485-8350
Fax 0 0
Email 0 0
clinicaltrials@unither.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04084678