Pulmonary Arterial HypertensionPhase 2NCT02279745
Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
A Phase 2 study testing Ralinepag in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 46 sites in 10 countries.
Trial summary
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Ralinepag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 46 sitesin 10 countries
- Study dates
- 8 Jul 2015to 29 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document.
- Was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and was deemed an appropriate candidate for participation in a long-term extension study.
- Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal, or agreed to use an accepted method of birth control for at least 3 months prior to the first dose, during, and for at least 30 days after the last dose of study drug.
- Male subjects were either surgically sterile or agreed to use a condom with spermicide when sexually active with a female partner who was not using an acceptable method of birth control during the study and for 30 days after the last dose of study drug.
- Male and female subjects agreed not to participate in a conception process during the study and for 30 days after the last dose of study drug.
- Fulfilled all eligibility criteria for Study APD811-003 and completed the study as planned.
- Subjects who were assigned to placebo in Study APD811-003 and experienced clinical worsening in that study could enroll in Study APD811-007 after completing all end of study procedures per protocol, including RHC, for Study APD811-003 and had their data locked.
Who cannot join
- Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made for placebo-treated subjects who experienced a clinical worsening event.
- Female •subjects who wished to become pregnant.
- Systolic blood pressure <90 mmHg at Baseline.
- Other severe acute or chronic medical or laboratory abnormalities that could have increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry into this study.
Trial locations and contacts
46 sites in 10 countries.
46 sites in 10 countries
United States18 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Boston University Medical Center General Clinical Research Unit (GCRU)
Boston, Massachusetts, 02118
UC Health
Cincinnati, Ohio, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
Columbus, Ohio, 43221
UT Southwestern Medical Center
Dallas, Texas, 75390
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
UPMC, Presbyterian
Pittsburgh, Pennsylvania, 15229
Chest Medicine Associates
Portland, Maine, 04106
University of California Davis Medical Center
Sacramento, California, 95817
Harbor-UCLA Medical Center
Torrance, California, 90502
Cleveland Clinic Florida
Weston, Florida, 33331
Australia5 sites
The Prince Charles Hospital
Chermside, Queensland, 4032
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Fitzroy, Victoria, 3065
Royal Hobart Hospital
Hobart, Tasmania, 7001
Fiona Stanley Hospital
Murdoch, 6150
Hungary5 sites
Gottsegen Gyorgy Orszagos Kardiológiai lntézet - National Institute of Cardiology, Department of Adult Cardiology
Budapest, 1051
Semmelweis University, Department of Pulmonology - Semmelweis Egyetem Pulmonológiai Klinika
Budapest, 1051
University of Szeged Faculty of Medicine, 2nd Department of Medicine and Cardiology Center, Albert Szent-Györyi Clinical Center - SZTE ÁOK Szent-Györgyi A lbert Klinikai Központ I I. sz. Belgyógyászati Klini ka és Kard ilógiai Központ
Budapest, 1051
University of Pecs, Medical School, Heart Institute - Pécsi Tudományegyetem, Klinikai Központ, Szívgyógyászati Klinika
Budapest, 105
University of Derecen Clinical Research Center Cardiology and Cardiac Surgery Department - Debreceni Egyetem Klinikai Kozpont Kardiologiai es Szivsebeszeti Klinika
Debrecen, 4032
Poland3 sites
Medical University of Bialystok Clinical Hospital Cardiology Clinic - Uniwersytecki Szpital Kliniczny, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego
Krakow, 15-276
John Paul II Hospital in Cracov Department of Cardiac and Vascular Diseases - Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Chorób Serca i Naczyń
Krakow, 31-202
Biegański Provincial Specialist Hospital Department of Cardiology - Wojewódzki Szpital Specjalistyczny im. dr Wł. Biegańskiego w Lodzi, Oddział Kardiologiczny
Lodz, 90-647
Romania3 sites
"Prof. Dr. C.C. Iliescu" Institute of Cardiovascular Diseases, Department of Clinic Cardiology III - Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Secţia Clinica Cardiologie fIJ
Bucharest, 022322
"Marius Nasta" Institute of Pneumoftiziology, Department of Pneumoftiziology IV - Institutul de Pneumoftiziologie "Marius Nasta", Sectia Clinica Pneumoftiziologie IV
Bucharest, 050159
"Dr. Victor Babes" Clinic Hospital for Infesctious Diseases and Pneumoftiziology, Department of Clinic Pneumology II
Timișoara, 300310
Serbia3 sites
Clinical Centre of Serbia (CCS), Cardiology Clinic - Klinicki Centar SrЬije, Klinika za kardiologiju
Belgrade, 11000
Кlinicko-bolnicki Centar Zemun, Кlinika za internu medicinu, Sluzba za kardiologiju
Belgrade, 11080
Institut za plucne bolesti Vojvodine Sremska Kamenica, Klinika za urgcntnu pulmologiju, Odeljcnje intenzivne nege - Institute of Pulmonary Diseases of Vojvodina Sremska Kamenica (IPDVSK), The Clinic for Urgent Pulmonology, ICU - Intensive Care Unit
Kamenitz, 21204
Spain3 sites
Clinic Hospital of Barcelona, Department of Pneumology
Barcelona, 08036
General University Hospital Vall d'Hebron, Department of Pneumology
Barcelona, 08036
Hospital 12th of October, Department of Cardiology
Madrid, 28041
Bulgaria2 sites
Multiprofile Hospital for Active Treatment "National Heart Hospital" EAD, Clinic of Cardiology
Sofia, 1000
Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic
Sofia, 1303
Czechia2 sites
Department of Internal Medicine I - Cardiology, University Hospital Olomouc
Olomouc, 77900
Second Internal Clinic - Clinic of Cardiology and Angiology, 1st Faculty of Medicine, Charles University in Prague, General University Hospital in Prague
Prague, 12808
Slovakia2 sites
Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases - Oddelenie zlyhávania a transplantácie srdca, Národný ústav srdcových a cievnych chorôb, a.s.
Bratislava, 833 48
Cardiology department, East Slovak Institute for Cardiovascular Diseases - Kardiologické oddelenie Klinika kardiológie , Východoslovenský ústav srdcových a cievnych chorôb, a.s
Košice, 4011
About this study
Official title: An Open-label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.
Read the detailed description
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with WHO Group 1 PAH who completed Study APD811-003. Subjects who completed Study APD811-003 and met eligibility criteria for Study APD811-007 were enrolled. Additionally, placebo-treated subjects who discontinued study drug treatment due to clinical worsening in Study APD811-003 were permitted to enroll in Study APD811-007, upon approval of the medical monitor, provided that all end of study procedures including right heart catheterization (RHC) were performed per the study protocol. The Week 25 Visit in Study APD811-003 served as the Baseline Visit for Study APD811-007.
All subjects enrolled in Study APD811-007 received open-label treatment with ralinepag. The starting dose and titration schedule were individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003. Adjustments in the dose and titration schedule were made according to subject tolerability.
After an individual subject completed Study APD811-003 and that subject's database was locked, subject unblinding occurred. Subjects on active treatment (ralinepag) remained on their current dose and had onsite clinical assessments performed every 3 months until the subject was discontinued from the study.
Subjects in the placebo treatment group underwent a dose titration period until a stable, maximum tolerated dose (MTD) was reached (up to 9 weeks), followed by a treatment period after the MTD was determined during which monthly onsite clinic assessments were performed for the first 3 months and then every 3 months until the subject was discontinued from the study or the study was terminated. Dose reductions could be made at any time for safety reasons. Incremental dose increases were also allowed during the Treatment Period at the discretion of the Investigator (as clinically indicated) and according to the stepwise titration scheme.
Subjects were assessed for clinical worsening during each clinic visit. If clinical worsening was confirmed, the Investigator could have opted to either continue treatment with ralinepag at the current dose, increase the dose of ralinepag, interrupt treatment, or discontinue the subject at his/her discretion.
In addition, attempts were made to contact all subjects at the time of Study APD811-007 termination to assess their vital (mortality) status. After the last subject enrolled in Study APD811-007 completed approximately 6 months of the study, a cumulative all-subject data analysis was performed for all subjects who entered the study. Subjects continued to have visits to the clinic every 3 months until the Sponsor discontinued the study. At the time of the Sponsor's decision to discontinue the study, all ongoing subjects completed an End of Study Visit. A 28-day Follow-up Visit was conducted to ensure appropriate subject safety. Subjects who remained on ralinepag were eligible to transition into the Phase 3 open-label extension study (ROR-PH-303) prior to APD811-007 study termination. For those subjects that did not enroll in Study ROR-PH-303, a 28-day Follow-up Visit was conducted to evaluate ongoing subject safety, including survival status.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Ralinepag
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RalinepagDrug
Also called APD811
Active
| Study group | Role | What they receive |
|---|---|---|
| Oral Ralinepag | Experimental | Ralinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration. Receives: Drug: Ralinepag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pulmonary Vascular Resistance
Pulmonary vascular resistance was collected by right heart catheterization (RHC).
Measured: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Change From Baseline in Cardiac Output
Cardiac output was collected by right heart catheterization (RHC).
Measured: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Change From Baseline in Cardiac Index
Cardiac index was collected by right heart catheterization (RHC).
Measured: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Change From Baseline in Mean Pulmonary Arterial Pressure
Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).
Measured: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Secondary outcomes (3)
Time From Randomization to the First Protocol-defined Clinical Worsening Event
Clinical worsening events were defined as death, or onset of a treatment-emergent adverse event (AE) with a fatal outcome occurring ≤14 days after treatment discontinuation; hospitalization for worsening PAH, heart-lung or lung transplant, or atrial septostomy; necessity of addition (or dose change) of any prostacyclin/prostacyclin analogue, phosphodiesterase type 5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC), or endothelin receptor antagonist (ERA); and the combined occurrence of a decrease in 6-Minute Walk Distance (6MWD) by at least 20% from Baseline, confirmed on two 6-Minute Walk Tests (6MWTs) on different days; worsening in WHO/New York Heart Association (NYHA) Functional Class (FC) from Baseline; and appearance of or worsening of signs/symptoms of right heart failure that did not respond to optimized oral diuretic therapy.
Measured: From Baseline to 28 days following discontinuation of study drug, up to 235 weeks.
Change From Baseline in 6MWD
6MWD was measured at Baseline (prior to starting study drug) and every 3 months thereafter including the End of Study Visit.
Measured: From Baseline to discontinuation of study drug, up to 235 weeks
Change From Baseline in WHO/NYHA FC
WHO/NYHA FC was measured at Baseline (prior to starting study drug) and every 3 months thereafter including at the End of Study and 28-Day Follow-up Visits. FC recorded as I, II, III, or IV based on the following:
I: PH but without limitation of physical activity; physical activity without undue dyspnea or fatigue, chest pain or near syncope.
II: PH with slight limitation of physical activity; physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
III: PH with marked limitation of physical activity; less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope.
IV: PH with inability to carry out any physical activity without symptoms. Signs of right heart failure. Dyspnea and/or fatigue at rest. Discomfort is increased by any physical activity.
Measured: From Baseline to 28 days following discontinuation of study drug, up to 235 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start8 Jul 2015
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279745
- Sponsor's protocol ID
- APD811-007
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2014
- Last updated
- 22 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02279745
- Acronym / sponsor ID
- APD811-007
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 22 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.
Detailed description
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with WHO Group 1 PAH who completed Study APD811-003. Subjects who completed Study APD811-003 and met eligibility criteria for Study APD811-007 were enrolled. Additionally, placebo-treated subjects who discontinued study drug treatment due to clinical worsening in Study APD811-003 were permitted to enroll in Study APD811-007, upon approval of the medical monitor, provided that all end of study procedures including right heart catheterization (RHC) were performed per the study protocol. The Week 25 Visit in Study APD811-003 served as the Baseline Visit for Study APD811-007.
All subjects enrolled in Study APD811-007 received open-label treatment with ralinepag. The starting dose and titration schedule were individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003. Adjustments in the dose and titration schedule were made according to subject tolerability.
After an individual subject completed Study APD811-003 and that subject's database was locked, subject unblinding occurred. Subjects on active treatment (ralinepag) remained on their current dose and had onsite clinical assessments performed every 3 months until the subject was discontinued from the study.
Subjects in the placebo treatment group underwent a dose titration period until a stable, maximum tolerated dose (MTD) was reached (up to 9 weeks), followed by a treatment period after the MTD was determined during which monthly onsite clinic assessments were performed for the first 3 months and then every 3 months until the subject was discontinued from the study or the study was terminated. Dose reductions could be made at any time for safety reasons. Incremental dose increases were also allowed during the Treatment Period at the discretion of the Investigator (as clinically indicated) and according to the stepwise titration scheme.
Subjects were assessed for clinical worsening during each clinic visit. If clinical worsening was confirmed, the Investigator could have opted to either continue treatment with ralinepag at the current dose, increase the dose of ralinepag, interrupt treatment, or discontinue the subject at his/her discretion.
In addition, attempts were made to contact all subjects at the time of Study APD811-007 termination to assess their vital (mortality) status. After the last subject enrolled in Study APD811-007 completed approximately 6 months of the study, a cumulative all-subject data analysis was performed for all subjects who entered the study. Subjects continued to have visits to the clinic every 3 months until the Sponsor discontinued the study. At the time of the Sponsor's decision to discontinue the study, all ongoing subjects completed an End of Study Visit. A 28-day Follow-up Visit was conducted to ensure appropriate subject safety. Subjects who remained on ralinepag were eligible to transition into the Phase 3 open-label extension study (ROR-PH-303) prior to APD811-007 study termination. For those subjects that did not enroll in Study ROR-PH-303, a 28-day Follow-up Visit was conducted to evaluate ongoing subject safety, including survival status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Ralinepag | Experimental | Drug: RalinepagRalinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Evidence of a personally signed and dated informed consent document.
- Was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and was deemed an appropriate candidate for participation in a long-term extension study.
- Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal, or agreed to use an accepted method of birth control for at least 3 months prior to the first dose, during, and for at least 30 days after the last dose of study drug.
- Male subjects were either surgically sterile or agreed to use a condom with spermicide when sexually active with a female partner who was not using an acceptable method of birth control during the study and for 30 days after the last dose of study drug.
- Male and female subjects agreed not to participate in a conception process during the study and for 30 days after the last dose of study drug.
Key exclusion criteria (4 listed)
- Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made for placebo-treated subjects who experienced a clinical worsening event.
- Female •subjects who wished to become pregnant.
- Systolic blood pressure <90 mmHg at Baseline.
- Other severe acute or chronic medical or laboratory abnormalities that could have increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RalinepagAlso: APD811Active | Drug | Oral Ralinepag |
Primary outcome
Change From Baseline in Pulmonary Vascular Resistance
Time frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Pulmonary vascular resistance was collected by right heart catheterization (RHC).
Change From Baseline in Cardiac Output
Time frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Cardiac output was collected by right heart catheterization (RHC).
Change From Baseline in Cardiac Index
Time frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Cardiac index was collected by right heart catheterization (RHC).
Change From Baseline in Mean Pulmonary Arterial Pressure
Time frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).
3 secondary outcomes
Time From Randomization to the First Protocol-defined Clinical Worsening Event
Time frame: From Baseline to 28 days following discontinuation of study drug, up to 235 weeks.
Change From Baseline in 6MWD
Time frame: From Baseline to discontinuation of study drug, up to 235 weeks
Change From Baseline in WHO/NYHA FC
Time frame: From Baseline to 28 days following discontinuation of study drug, up to 235 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ralinepag in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 46 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Australia, Hungary, Poland, Romania and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pulmonary Vascular Resistance (time frame: At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.