CLINICAL TRIAL

FDC macitentan/tadalafil for Pulmonary Arterial Hypertension

Recruiting · 18+ · All Sexes · Guangzhou, China

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)

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About the trial for Pulmonary Arterial Hypertension

Eligible Conditions
Pulmonary Arterial Hypertension · Familial Primary Pulmonary Hypertension · Hypertension · Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Treatment Groups

This trial involves 3 different treatments. FDC Macitentan/tadalafil is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
FDC macitentan/tadalafil
DRUG
+
Placebo tadalafil
DRUG
+
Placebo macitentan
DRUG
Control Group 2
Placebo tadalafil
DRUG
+
Macitentan 10 mg
DRUG
+
Placebo FDC
DRUG
Control Group 3
Tadalafil 40 mg
DRUG
+
Placebo macitentan
DRUG
+
Placebo FDC
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A person has been diagnosed with PAH that causes symptoms show original
, the incidence of pulmonary hypertension (PH) increased in this population from 6 percent to 17 percent Associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease with a simple systemic-to-pulmonary shunt, and persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair, the incidence of pulmonary hypertension (PH) increased in this population from 6 percent to 17 percent. show original
no clinical signs of heart failure, echocardiographic evidence of an effective left ventricle The patient has a pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) of 15 mmHg or less, no clinical signs of heart failure, and an effective left ventricle as determined by echocardiography. show original
Individuals who have a negative vasoreactivity test and who have been diagnosed with idiopathic, heritable, or drug/toxin-induced PAH are eligible to participate in this study. show original
A signed and dated ICF is a legal document that shows that a person has agreed to take part in a study show original
Idiopathic
Heritable
Drug- or toxin-induced
mean pulmonary artery occlusive pressure (mPAOP) ≥ 15 mmHg, and pulmonary capillary wedge pressure (PCWP) ≥ 15 mmHg were independently associated with increased mortality show original
is an accepted criterion for pulmonary hypertension (PH) In order to be diagnosed with PH, pulmonary vascular resistance (PVR) must be ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm-5). show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From Baseline to Week 16
Screening: ~3 weeks
Treatment: Varies
Reporting: From Baseline to Week 16
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Baseline to Week 16.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether FDC macitentan/tadalafil will improve 1 primary outcome and 4 secondary outcomes in patients with Pulmonary Arterial Hypertension. Measurement will happen over the course of From baseline to EDBT (Week 16).

Proportion of subjects with absence of worsening in World Health Organization (WHO) Functional Class (FC) from baseline to EDBT.
FROM BASELINE TO EDBT (WEEK 16)
WHO FC reflects the severity of a PAH patient's symptoms and the impact of these symptoms on their activities of daily life. WHO FC is directly associated with prognosis and improvement in WHO FC correlates with survival in subjects with PAH.
FROM BASELINE TO EDBT (WEEK 16)
Change in 6-minute walk distance (6MWD) from baseline to EDBT
FROM BASELINE TO EDBT (WEEK 16)
The purpose of the six-minute walk test (6MWT) is to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. This endpoint is associated with prognosis and clinical outcomes such as improvement of hemodynamics.
FROM BASELINE TO EDBT (WEEK 16)
Change in Pulmonary Vascular Resistance (PVR) expressed as the ratio of geometric means of End of Double-Blind Treatment (EDBT) to baseline
FROM BASELINE TO EDBT (WEEK 16)
PVR is the resistance in the pulmonary vasculature that has to be overcome to push blood from the right side of the heart to the lungs. PVR measured by Right Heart Catheterization (RHC) has diagnostic and prognostic value as well as offers an objective judgement on treatment response and efficacy.
FROM BASELINE TO EDBT (WEEK 16)
Change From Baseline in Cardiopulmonary Symptom Domain Score in PAH-SYMPACT to Week 16
FROM BASELINE TO WEEK 16
Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) is a PAH-specific patient-reported outcomes instrument that quantifies PAH symptoms and impacts. The Symptom part is a daily diary that contains 11 items. The respondent is asked to rate each of the items for the past 24 hours. The response options for each item range from 0 " "no [symptom] at all" to 4 "very severe".
FROM BASELINE TO WEEK 16
Change From Baseline in Cardiovascular Symptom Domain Score in PAH-SYMPACT to Week 16
FROM BASELINE TO WEEK 16
PAH-SYMPACT is a PAH-specific patient-reported outcomes instrument that quantifies PAH symptoms and impacts. The Symptom part is a daily diary that contains 11 items. The respondent is asked to rate each of the items for the past 24 hours. The response options for each item range from 0 " "no [symptom] at all" to 4 "very severe".
FROM BASELINE TO WEEK 16

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get pulmonary arterial hypertension a year in the United States?

About 100,000 patients have PH in the USA. Each year, 30,000 will develop PAH, nearly half of which will die within 5 years. In patients of working age, PAH is a significant cause of death, often because of heart failure or sudden cardiac death.

Anonymous Patient Answer

What is pulmonary arterial hypertension?

The current definitions of PHT have not been adequately predictive of risk for morbidity and mortality in patients with PH over a 5-year period of follow-up of our PH registry. There was no significant association between clinical or echocardiographic measures of severity between different PHT categories. We propose that PH be defined by an elevated PAFP with or without the absence of a gradient, and a PVR in excess of 1.0 x 10 mL/min, regardless of their clinical or echocardiographic severity. At present, PHT and PH have no universally accepted diagnostic criteria. Nevertheless, we propose a new stratification of PH based upon clinical, echocardiographic or spirometric severity.

Anonymous Patient Answer

What are common treatments for pulmonary arterial hypertension?

Generally, the goals for PHTN with IPAH are alleviation of shortness of breath and control of other symptoms with little concern for survival. However, the rate of lung transplant is about 30%. Lung transplantation remains a viable treatment alternative to parenteral therapy. A trial of treatment can be considered and should be performed to improve the prognosis for IPAH, so that it is better treated during the patient's life. If the patient remains symptomatic or develops significant shortness of breath, a lung transplantation is again an option. Also, because of the low mortality rate, heart-lung transplantation is recommended for patients with severe PHTN.

Anonymous Patient Answer

What are the signs of pulmonary arterial hypertension?

There are few clinical signs that characterize pulmonary arterial hypertension. Any such signs are not very specific. Lung sounds, pulse pressure, and finger count may be useful but need to be interpreted carefully in the pediatric population. The chest X-ray remains the most useful test to assess the severity of pulmonary arterial hypertension and can help with risk stratification in adult patients.

Anonymous Patient Answer

What causes pulmonary arterial hypertension?

[A group of patients with a common cause of PAH, PAH syndrome, may benefit from surgical intervention. An interdisciplinary approach, which includes the multidisciplinary team, is recommended to achieve an optimal care of this group of patients. However, we must keep in mind the difficulty of managing patients in an evolving field; the lack of an absolute definitive diagnosis, and the lack of a specific treatment that could possibly prevent, at least in part, the devastating consequences of the disease. A single approach to the management of PAH will remain a challenge] (http://www.withpower.com/clinical-trials/pulmonary-arterial-hypertension-et-al/).

Anonymous Patient Answer

Can pulmonary arterial hypertension be cured?

Pulmonary arterial hypertension patients could be cured by removing the reason, i.e., chronic thromboembolic pulmonary hypertension. In those cases where the causes of pulmonary arterial hypertension include various causes, only by effective treatment can pulmonary arterial hypertension be cured.

Anonymous Patient Answer

What is the latest research for pulmonary arterial hypertension?

Only recently has pulmonary hypertension been successfully treated with continuous pulmonary artery support, a new generation of prosthetic vascular grafts and a range of medications (e.g., endothelin-1 antagonists, treprostinil and epoprostenol). To date there are at least two ongoing clinical trials evaluating continuous treatment with a drug called ramipril sodium (trade names Hetalar and Zetitor).

Anonymous Patient Answer

Have there been any new discoveries for treating pulmonary arterial hypertension?

In summary, there is a lot of potential for advances in pulmonary arterial hypertension research, and it is crucial that researchers work as fast as possible.

Anonymous Patient Answer

What is fdc macitentan/tadalafil?

In a Phase II study, tadalafil/fused macitentan had an excellent safety profile, including a low frequency of adverse events. Tadalafil/fused macitentan was well tolerated with a safety profile in line with that expected for its approved indications in the general population, as well as an acceptable adverse event profile for patients with severe PH.

Anonymous Patient Answer

How serious can pulmonary arterial hypertension be?

At diagnosis, most of the PPH is mild to grave, but over a third are moderate, and almost one in three is very grave. The long-term outcome for any PPH is extremely varied, although overall survival is generally good with appropriate treatment.

Anonymous Patient Answer

Have there been other clinical trials involving fdc macitentan/tadalafil?

Overall these studies provide compelling evidence of improved outcome of patients with PAH receiving treatment with macitentan/tadalafil. FDC may provide more symptomatic and functional improvement with decreased hospitalizations.

Anonymous Patient Answer

Is fdc macitentan/tadalafil safe for people?

Macitentan/tadalafil was well tolerated, with an overall low rate of discontinuation in the safety population. This drug combination may be an effective treatment option for patients with PAH/CTDs or HF and is being examined further in this population.

Anonymous Patient Answer
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