Clinical Trials in Canada

The goal of the study is to learn what happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. The second goal is to lear about the safety of sotatercept and if people tolerate it.

The PROSERA Study is a Phase 3 clinical research study designed to help researchers understand whether an inhaled investigational product called seralutinib may be an effective and safe future treatment for adults with pulmonary arterial hypertension. The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH).

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

The investigators' central hypothesis is that early combination therapy with two pulmonary-arterial-hypertension-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 functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) due to heart failure with preserved ejection fraction (HFpEF). Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

This was a two-part (Phase 2/3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension. Phase 2 assessed three different doses of MK-5475 compared to placebo. Phase 3’s purpose was 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.

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

The objectives of this study were 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 pulmonary arterial hypertension.

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

This study evaluated the impact of a 12 week 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.

Extended 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.

This study aimed to demonstrate that the fixed-dose combination (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 evaluated the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two pulmonary-arterial-hypertension-approved therapies given as monotherapy to further confirm the added value of the FDC.

The investigators looked at whether or not metabolic syndrome seen in pulmonary arterial hypertension patients impairs mitochondrial functions through an IRS1/PPARg/PGC1-dependent mechanism, which would ultimately decrease skeletal muscle function and perfusion, and thus overall exercise capacity.

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.

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 Group 1 PAH.

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.

The purpose of this study was 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.

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).

The primary objective of this study was 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.

To evaluate the safety and efficacy of first-line combination therapy using riociguat with ambrisentan in patients with Pulmonary Arterial Hypertension (PAH).

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.

This study was an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who had 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.

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)

The aim of this study was 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.