RESEARCH

Clinical Trials in Canada

In the past couple of decades, PH medical research has evolved immensely throughout the world. Medical professionals are delving deeper into the science and uncovering new information every day. And while this has taken place internationally, we are incredibly fortunate to have leading research and clinical trials taking place right here in Canada.

How can I participate in PH research?

Patient participation in research is essential to making scientific advancements in the diagnosis and treatment of PH. Numerous early-stage and clinical-stage research studies are currently taking place in research centres throughout Canada. Check out the list below for more information on studies that are currently recruiting participants. For additional information, speak to your PH medical team or visit ClinicalTrials.gov.

Disclaimer: This information is updated every 4-6 months. The latest update was in October 2023. PHA Canada is not responsible for errors or omissions.

Thanks to advancements in research, many PH treatments are available in Canada. However, they aren’t always available through public funding in every province and territory. This means people in some parts of the country don’t have equal access to the vital treatments they need. Visit our advocacy section to learn more and join us in representing a united PH community.

Recruiting

A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

POPULATION:

START DATE:

END DATE:

PHASE:

Type 2 PH

April 24, 2023

April 23, 2025

AstraZeneca

STUDY SUMMARY

This study is intended to assess the ability of AZD3427 to reduce pulmonary vascular resistance (PVR) after 24 weeks of treatment in participants with heart failure (HF) and pulmonary hypertension (PH) Group 2

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

August 1, 2022

September 30, 2026

III

Johns Hopkins University

STUDY SUMMARY

The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

POPULATION:

START DATE:

END DATE:

PHASE:

CPC-PH

December 29, 2021

May 19, 2026

Acceleron Pharma, Inc.

STUDY SUMMARY

The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

POPULATION:

START DATE:

END DATE:

PHASE:

Type 2 PH

October 19, 2021

June 1, 2024

Observational

Mount Sinai Hospital

STUDY SUMMARY

Prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

May 12, 2021

September 30, 2027

III

Acceleron Pharma, Inc.

STUDY SUMMARY

The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

February 14, 2020

June 30, 2024

N/A

V-Wave Ltd

STUDY SUMMARY

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

Assessment of Recovery of Functional Capillary Surface Area in Patients Undergoing a Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

CTEPH

January 30, 2023

January 30, 2025

N/A

Jewish General Hospital

STUDY SUMMARY

Many patients with CTEPH are treated with balloon pulmonary angioplasty [BPA] which mechanically opens the narrow pulmonary arteries. It is unclear how much downstream functional pulmonary capillary surface area [FCSA] is recovered during BPA. We plan to measure FCSAIn CTEPH patients, before and after a session of BPA.

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

March 18, 2022

June 30, 2028

III

Acceleron Pharma, Inc.

STUDY SUMMARY

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

December 2, 2021

December 1, 2024

II, III

Aerovate Therapeutics

STUDY SUMMARY

IMPAHCT:A study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants (CARE PAH)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

August 18, 2021

March 15, 2027

ACTELION

STUDY SUMMARY

The purpose of this study is to describe the time to all-cause death and time to death due to pulmonary arterial hypertension (PAH) or first hospitalization due to PAH in the overall study population and within each cohort.

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

June 30, 2020

August 27, 2025

III

Actelion

STUDY SUMMARY

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

Pediatric PH

January 16, 2020

December 9, 2024

III

Actelion

STUDY SUMMARY

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

November 2, 2022

December 31, 2025

III

Aerovate Therapeutics

STUDY SUMMARY

IMPAHCT-FUL:A follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/_A011-16) (CADENCE)

POPULATION:

START DATE:

END DATE:

PHASE:

Type 2 PH

December 29, 2021

October 31, 2025

Acceleron Pharma, Inc.

STUDY SUMMARY

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH WHO FC III or IV

December 1, 2021

November 30, 2025

III

Acceleron Pharma, Inc.

STUDY SUMMARY

The objective of this study is to evaluate the effects of sotatercept versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of �24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

May 19, 2021

February 9, 2026

II, III

Merck Sharp & Dohme LLC

STUDY SUMMARY

The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years.

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

March 5, 2020

April 24, 2024

Observational

Duke University

STUDY SUMMARY

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

POPULATION:

START DATE:

END DATE:

PHASE:

Pediatric PH

October 1, 2014

December 1, 2030

Observational

University of Colorado, Denver

STUDY SUMMARY

Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

Enrolling by Invitation

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

2019-09-23

2024-09

III

United Therapeutics

STUDY SUMMARY

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Active (not recruiting)

A Clinical Study to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Conditions

POPULATION:

START DATE:

END DATE:

PHASE:

Pediatric PAH

Mar 28, 2022

Dec 31, 2026

Actelion

STUDY SUMMARY

The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (_) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Conditions

POPULATION:

START DATE:

END DATE:

PHASE:

LV Systolic Dysfunction associated PH

Apr 14, 2010

Dec 31, 2025

Bayer

STUDY SUMMARY

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag (SPHINX)

POPULATION:

START DATE:

END DATE:

PHASE:

Sarcoidosis associated PH (SAPH)

Feb 26, 2021

Sept 15, 2024

ACTELION

STUDY SUMMARY

The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

CTEPH

Jul 7, 2020

May 14, 2024

III

Actelion

STUDY SUMMARY

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Past Trials

Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

September 28, 2017

December 1, 2023

II, III

Northern Therapeutics

STUDY SUMMARY

The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy.

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

March 15, 2021

February 1, 2023

ALTAVANT SCIENCES GMBH

STUDY SUMMARY

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients. Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH.

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

December 14, 2020

November 1, 2022

GB002, INC., A WHOLLY OWNED SUBSIDIARY OF GOSSAMER BIO, INC.

STUDY SUMMARY

The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Olaparib for PAH: a Multicenter Clinical Trial

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

November 20, 2019

December 31, 2023

I, II

Laval University

STUDY SUMMARY

The primary objective of this Phase 1B study is to confirm the safety of using olaparib in PAH patients, and precise the sample size of a future Phase 2 trial. In addition to safety, efficacy signals will thus be assessed.

Skeletal Muscle Mitochondrial Abnormalities and the Metabolic Syndrome in PAH

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

June 1, 2019

December 1, 2022

OBSERVATIONAL

LAVAL UNIVERSITY

STUDY SUMMARY

The investigators propose to determine whether or not MS seen in PAH patients impairs mitochondrial functions through an IRS1/PPARg/PGC1-dependent mechanism, which will ultimately decrease skeletal muscle function and perfusion, and thus overall exercise capacity.

Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

Pediatric PH

June 20, 2018

June 1, 2023

Observational

The Hospital for Sick Children

STUDY SUMMARY

To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.

Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

Newborn PH

August 31, 2017

August 1, 2023

Observational

Mount Sinai Hospital,

STUDY SUMMARY

The primary objective of this study is to develop new, sensitive, quantitative echocardiographic diagnostic criteria which will allow for the identification of extreme preterm neonates suffering from significantly high pressure in their pulmonary blood vessels, early in postnatal course, when the disease is likely to be most amenable to preventative/curative treatment.

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

May 1, 2012

August 1, 2021

III

UNITED THERAPEUTICS

STUDY SUMMARY

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension (REVAMP)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

June 1, 2021

December 1, 2021

NOT APPLICABLE

UNIVERSITY OF CALGARY

STUDY SUMMARY

This study will determine the feasibility of a mobile application-based home exercise rehabilitation program for patients with pulmonary hypertension. The principal investigator and co-investigator will be unaware of allocation until after the beginning of the exercise program. There will be no blinding after intervention begins, as is typical with studies of exercise intervention.

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

January 25, 2021

December 1, 2022

III

ACCELERON PHARMA INC.

STUDY SUMMARY

The objectives of this study are to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH (Moved to Past Trials section)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

October 29, 2020

July 1, 2023

III

United Therapeutics

STUDY 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

Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study (APPRoAcH-p)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

August 22, 2019

August 1, 2021

STEEVE PROVENCHER

STUDY SUMMARY

The main objective of this proposal is to extend the investigator's preclinical findings on the role of epigenetics and DNA damage and Bromodomain-Containing Protein 4 (BRD4) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH).

Dyspnea in Chronic Thromboembolic Pulmonary Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

CTEPH

November 1, 2018

September 30, 2022

OBSERVATIONAL

QUEEN'S UNIVERSITY

STUDY SUMMARY

Using new sophisticated technology, the investigators will determine the root causes of perceived breathing difficulty. The investigators will test the idea that breathlessness is fundamentally the result of increased drive to breathe from control centers in the brain. The investigators will measure drive to breathe by measuring the electrical activity descending from the brain to the main muscle of breathing - the diaphragm.

Spironolactone Therapy in Chronic Stable Right HF Trial (STAR-HF)

POPULATION:

START DATE:

END DATE:

PHASE:

RIGHT HEART FAILURE

April 1, 2018

September 30, 2022

OTTAWA HEART INSTITUTE RESEARCH CORPORATION.

STUDY SUMMARY

The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure.

Upfront Combination Pulmonary Arterial Hypertension Therapy

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

April 26, 2016

December 1, 2020

UNIVERSITY OF CALGARY

STUDY SUMMARY

This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.

ACT-293987 in Pulmonary Arterial Hypertension

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

July 7, 2010

April 2, 2021

III

ACTELION

STUDY SUMMARY

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation

POPULATION:

START DATE:

END DATE:

PHASE:

Radiotherapy induced PH

June 1, 2021

June 1, 2023

N/A

University Health Network, Toronto

STUDY SUMMARY

The purpose of this study is to be able to Demonstrate correlation of combined PET/MR and plasma metabolomics markers in patients at risk of developing cardiopulmonary disfunction after RT.

A Study to Find Out if Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interv

POPULATION:

START DATE:

END DATE:

PHASE:

CTEPH

January 25, 2021

October 30, 2022

ACTELION

STUDY SUMMARY

Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in subjects with inoperable or persistent/recurrent CTEPH.

Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

March 1, 2020

March 1, 2021

NOT APPLICABLE

LAVAL UNIVERSITY

STUDY SUMMARY

In this study, we intend to evaluate the impact of a 12 weeks home-based rehabilitation program on peripheral muscle function and metabolism, focusing on lipid infiltration, oxidative metabolism and epigenetic factors that can be involved in metabolic syndrome, in patients with Pulmonary Arterial Hypertension.

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

July 29, 2019

August 23, 2022

III

Actelion

STUDY SUMMARY

This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

POPULATION:

START DATE:

END DATE:

PHASE:

PAH

August 30, 2018

December 1, 2023

III

United Therapeutics

STUDY SUMMARY

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

POPULATION:

START DATE:

END DATE:

PHASE:

Pediatric PAH

October 24, 2017

December 23, 2023

III

Actelion

STUDY SUMMARY

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension (TOPP-2)

POPULATION:

START DATE:

END DATE:

PHASE:

PEDIATRIC PULMONARY HYPERTENSION

August 1, 2015

December 1, 2022

OBSERVATIONAL

ASSOCIATION FOR PEDIATRIC PULMONARY HYPERTENSION

STUDY SUMMARY

The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Clinical Trials in Canada

How can I participate in PH research?

Recruiting

A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

Assessment of Recovery of Functional Capillary Surface Area in Patients Undergoing a Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants (CARE PAH)

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/_A011-16) (CADENCE)

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

Enrolling by Invitation

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Active (not recruiting)

A Clinical Study to Confirm the Doses of Selexipag in Children With Pulmonary Arterial HypertensionConditions

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic DysfunctionConditions

A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag (SPHINX)

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Past Trials

Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Olaparib for PAH: a Multicenter Clinical Trial

Skeletal Muscle Mitochondrial Abnormalities and the Metabolic Syndrome in PAH

Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Remote Exercise Program Delivery Using a Mobile Application for Pulmonary Arterial Hypertension (REVAMP)

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH (Moved to Past Trials section)

Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study (APPRoAcH-p)

Dyspnea in Chronic Thromboembolic Pulmonary Hypertension

Spironolactone Therapy in Chronic Stable Right HF Trial (STAR-HF)

Upfront Combination Pulmonary Arterial Hypertension Therapy

ACT-293987 in Pulmonary Arterial Hypertension

PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation

A Study to Find Out if Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interv

Home-based Exercise Training in Patients With Pulmonary Arterial Hypertension: Effect on Skeletal Muscular Function and Metabolism

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension (TOPP-2)

A Clinical Study to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Conditions

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Conditions