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JNJ-67896049 for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Golden Jubilee National Hospital, Glasgow, United KingdomPulmonary Arterial Hypertension+6 MoreJNJ-67896049 - Drug
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effects of selexipag on right ventricular function in people with pulmonary arterial hypertension.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Autologous EPCs transfected with human eNOS
2
low dose AV-101
1
Children ≥1 to <18 years old

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Up to 60 weeks

Baseline and week 26
Change form Baseline to Week 26 in N-Terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
Change from Baseline to Week 26 RV Global Longitudinal Strain (RVGLS) Assessed by MRI
Change from Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
Change from Baseline to Week 26 in RV Ejection Fraction (RVEF) Assessed by MRI
Change from Baseline to Week 26 in RV End-Diastolic Volume (RVEDV) Assessed by MRI
Change from Baseline to Week 26 in RV End-Systolic Volume (RVESV) Assessed by MRI
Change from Baseline to Week 26 in RV Mass Assessed by MRI
Change from Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Change of Baseline to Week 26 in World Health Organization Functional Class (WHO FC)
Baseline to week 26
Change from Baseline to Week 26 in Number of Non-Invasive Low-Risk Criteria Variable
Up to 52 weeks
Number of Participants with AEs Leading to Premature Discontinuation of Selexipag
Up to 56 weeks
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with Treatment-Emergent Marked Laboratory Abnormalities
Up to 60 weeks
Number of Participants with AEs of Special Interest
Number of Participants with Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Autologous EPCs transfected with human eNOS
3
low dose AV-101
2
Children ≥1 to <18 years old

Side Effects for

Selexipag
77%Headache
53%Diarrhoea
42%Nausea
38%Pain in Jaw
25%Vomiting
21%Pain in Extremity
21%Arthralgia
13%Dizziness
11%Myalgia
11%Dyspepsia
11%Upper Respiratory Tract Infection
9%Flushing
9%Nasopharyngitis
9%Nasal Congestion
9%Fatigue
8%Decreased Appetite
8%Back Pain
8%Dyspnoea
6%Oedema Peripheral
6%Cough
6%Epistaxis
4%Abdominal Pain Upper
4%Oropharyngeal Pain
4%Non-Cardiac Chest Pain
4%Palpitations
4%Rash
4%Lower Respiratory Tract Infection
2%Migraine
2%Respiratory Tract Infection
2%Right Ventricular Failure
2%Abdominal Distension
2%Atrial Flutter
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03078907) in the Selexipag ARM group. Side effects include: Headache with 77%, Diarrhoea with 53%, Nausea with 42%, Pain in Jaw with 38%, Vomiting with 25%.

Trial Design

1 Treatment Group

JNJ-67896049
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: JNJ-67896049 · No Placebo Group · Phase 4

JNJ-67896049
Drug
Experimental Group · 1 Intervention: JNJ-67896049 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 weeks

Who is running the clinical trial?

ActelionLead Sponsor
190 Previous Clinical Trials
38,668 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
18,844 Patients Enrolled for Pulmonary Arterial Hypertension
Actelion Clinical TrialStudy DirectorActelion
12 Previous Clinical Trials
4,002 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
3,237 Patients Enrolled for Pulmonary Arterial Hypertension

Eligibility Criteria

Age 18 - 64 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of high blood pressure in your lungs called pulmonary arterial hypertension (PAH), which is caused by one of the following: unknown reasons, hereditary factors, certain medications or toxins, connective tissue disease, or a specific type of congenital heart disease that was repaired at least one year ago.
References

Frequently Asked Questions

Is there an age restriction for this research trial?

"According to the criteria laid out for this clinical trial, only individuals between 18 and 64 years of age are eligible to participate." - Anonymous Online Contributor

Unverified Answer

What is the cap on participants in this research endeavor?

"Affirmative. According to the clinicaltrials.gov website, this medical research has been open for recruitment since July 7th 2021 and was recently revised on November 8th 2022. In total, 80 participants need to be found in 5 distinct healthcare centres." - Anonymous Online Contributor

Unverified Answer

What characteristics make a participant ideal for this clinical trial?

"This clinical trial is recruiting 80 participants who are between 18 and 64 years old, possess WHO FC II or III pulmonary arterial hypertension (PAH), with NT-proBNP greater than 300 ng/L at screening. Furthermore, 6MWD must be >=150m during the assessment period for eligibility. Additionally, female patients of childbearing potential need to have a negative serum pregnancy test before enrollment and monthly tests until 30 days after study intervention has concluded. The PAH etiology can belong to one of six groups according to WSPH classification: Idiopathic PAH; Heritable PAH; Drugs or toxins induced;" - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration given its stamp of approval to JNJ-67896049?

"There is substantial clinical data to support the safety of JNJ-67896049, thereby receiving a 3 on our 1-3 scale. This advanced phase 4 trial indicates that this medication has already been approved for use." - Anonymous Online Contributor

Unverified Answer

Is this the inaugural instance of this type of research?

"Currently, 5 active clinical studies involving JNJ-67896049 can be found in 45 cities and 43 countries. The first trial for this drug was conducted by Actelion Pharmaceuticals in 2018, enrolling a total of 63 patients and achieving Phase 2 approval status. In the past three years, 16 trials have been carried out since then." - Anonymous Online Contributor

Unverified Answer

Could you provide an estimate of the number of research centers conducting this trial?

"At present, 5 medical centres are recruiting for this trial; mainly within Greenville, Anderson and Tucson as well as two other locations. To ease the burden of travelling to appointments, it is recommended that you pick a facility close by if signing up." - Anonymous Online Contributor

Unverified Answer

Does this research project currently have open enrollment?

"According to the clinicaltrials.gov page, this trial is open and accepting patients. It was first published on July 7th 2021 with a later update on November 8th 2022." - Anonymous Online Contributor

Unverified Answer

Has any additional research been conducted concerning JNJ-67896049?

"JNJ-67896049 was first evaluated at UZ Gent in 2018, with 16 trials completed since then. Currently, 5 active trials are taking place; most of these studies are hosted out of Greenville, South Carolina." - Anonymous Online Contributor

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

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