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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02279745




Registration number
NCT02279745
Ethics application status
Date submitted
25/10/2014
Date registered
31/10/2014
Date last updated
23/04/2019

Titles & IDs
Public title
Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Scientific title
An Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
APD811-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Ralinepag - Ralinepag immediate release (IR) capsules of 0.01, 0.02, 0.03, 0.04 mg, and 0.10 mg per capsule or extended release (XR) tablets of 50, 250, and 400 mcg (0.05, 0.25 and 0.4 mg) for oral administration. The starting dose and titration schedule will be determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003.


Treatment: Drugs: Ralinepag
Active

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

Outcomes
Primary outcome [1] 0 0
Long-term safety assessed by adverse events up to 28 days following discontinuation of study drug - The number of adverse events will be computed overall and by treatment group in the parent study (Study APD811-003)
Timepoint [1] 0 0
From Baseline to 28 days following discontinuation of study drug.

Eligibility
Key inclusion criteria
- Evidence of a personally signed and dated informed consent document

- Is willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures and is deemed an appropriate candidate for participation in
a long-term extension study and administration of APD811

- Fulfilled all eligibility criteria for APD811-003 and completed the study as
planned

- Patients who discontinued for clinical worsening in APD811-003 and were assigned
to placebo and completed all end of study procedures including right heart
catheterization (RHC) may participate after their data from the APD811-003 study
is cleaned and locked
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due
to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not
complete the APD811 003 study for other reasons.

- Female patients who wish to become pregnant

- Systolic BP <90 mmHg at Baseline/Day 1

- Other severe acute or chronic medical or laboratory abnormality that may increase the
risk associated with study participation or investigational product administration or
may interfere with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this study

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
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
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Czechia
State/province [6] 0 0
Olomouc
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Hungary
State/province [8] 0 0
Pécs
Country [9] 0 0
Poland
State/province [9] 0 0
Bialystok
Country [10] 0 0
Romania
State/province [10] 0 0
Bucharest
Country [11] 0 0
Romania
State/province [11] 0 0
Timisoara
Country [12] 0 0
Serbia
State/province [12] 0 0
Belgrade
Country [13] 0 0
Serbia
State/province [13] 0 0
Sremska Kamenica
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid

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 open-label extension study to determine the long-term safety and
tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study,
APD811-003. Patients must have completed the APD811-003 study and must meet eligibility
criteria for APD811-007.
Trial website
https://clinicaltrials.gov/show/NCT02279745
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Isil Saib, MPH
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
Other publications