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Prostacyclin Receptor Agonist

JNJ-67896049 for Pulmonary Arterial Hypertension (RESTORE Trial)

Phase 4
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights

RESTORE Trial Summary

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

Eligible Conditions
  • Pulmonary Arterial Hypertension

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
Secondary outcome measures
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)
+11 more

Side effects data

From 2020 Phase 4 trial • 108 Patients • NCT03078907
77%
Headache
53%
Diarrhoea
42%
Nausea
38%
Pain in Jaw
25%
Vomiting
21%
Arthralgia
21%
Pain in Extremity
13%
Dizziness
11%
Dyspepsia
11%
Upper Respiratory Tract Infection
11%
Myalgia
9%
Flushing
9%
Nasopharyngitis
9%
Fatigue
9%
Nasal Congestion
8%
Dyspnoea
8%
Decreased Appetite
8%
Back Pain
6%
Oedema Peripheral
6%
Cough
6%
Epistaxis
4%
Palpitations
4%
Non-Cardiac Chest Pain
4%
Lower Respiratory Tract Infection
4%
Abdominal Pain Upper
4%
Oropharyngeal Pain
4%
Rash
2%
Respiratory Tract Infection
2%
Atrial Flutter
2%
Right Ventricular Failure
2%
Migraine
2%
Abdominal Distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Selexipag
Placebo

RESTORE Trial Design

1Treatment groups
Experimental Treatment
Group I: JNJ-67896049Experimental Treatment1 Intervention
Participants will receive JNJ-67896049 tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,684 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
15,976 Patients Enrolled for Pulmonary Arterial Hypertension
Actelion Clinical TrialStudy DirectorActelion
13 Previous Clinical Trials
1,022 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
370 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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;"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
2021. "A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04435782.
~2 spots leftby May 2025
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