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JNJ-67896049 for Pulmonary Arterial Hypertension (RESTORE Trial)
RESTORE Trial Summary
This trial will test the effects of selexipag on right ventricular function in people with pulmonary arterial hypertension.
- Pulmonary Arterial Hypertension
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESTORE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 108 Patients • NCT03078907RESTORE Trial Design
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Who is running the clinical trial?
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."
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."
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;"
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."
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."
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."
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."
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."
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