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Apabetalone for Pulmonary Arterial Hypertension (APPROACH-2 Trial)
APPROACH-2 Trial Summary
This trial is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in subjects with PAH.
APPROACH-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPPROACH-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APPROACH-2 Trial Design
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Who is running the clinical trial?
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- Your body mass index (BMI) is between 18 and 40.My pulmonary arterial hypertension is due to genetics, drugs, toxins, or related to a heart defect that was corrected over a year ago.I am postmenopausal, sterilized, using contraception, or not engaging in activities that could lead to pregnancy.If you can have a baby, you need to have a negative pregnancy test before starting the treatment.My heart or lung condition mildly or moderately affects my daily activities.I am between 18 and 75 years old, or up to 80 if I have scleroderma-related PAH.Your doctor thinks you may not live for more than 1 year because of other health issues.My pulmonary hypertension is not caused by left heart diseases, lung diseases, chronic blood clots, or multiple factors.My blood, liver, and kidney functions are within normal ranges.I have severe lung disease that affects my breathing.I have 3 or more risk factors for heart failure, such as being overweight, having diabetes, high blood pressure, heart disease, recent cancer or infection.I will use a condom and ensure my partner uses contraception during and for 3 months after my treatment.You are allergic to apabetalone or any of its ingredients.I am not currently using strong medication inhibitors or have stopped them for 2 weeks.Your heart rate when you are awake and resting is either lower than 50 beats per minute or higher than 110 beats per minute.I have not had major surgery in the last 2 weeks or have fully recovered from it.I started taking bosentan less than 6 months ago.Tests show that you have blood clots in your lungs.I might have a rare lung blood vessel disorder.My pulmonary arterial hypertension is due to HIV or liver issues.Your lung function is less than 40%.Your blood pressure is lower than 90 mmHg when your heart beats.My heart medication has been the same and stable for over 3 months.I can walk 150 meters or more without stopping.I am unable to give consent by myself.You are expected to live for at least 28 weeks.I was hospitalized for acute right ventricle failure within the last 30 days.Your pulmonary artery pressure is too high, and there is no immediate way to improve it.I have started or plan to start a heart and lung rehab program within the last 12 weeks.I haven't had a whole blood transfusion in the last 4 months.
- Group 1: Apabetalone
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the enrollment period ongoing for this investigation?
"Presently, this clinical trial is no longer seeking patients. The research was initially made available on October 1st 2022 and last updated April 22nd 2022. For those exploring alternative studies, there are currently 750 trials searching for participants suffering from pulmonary arterial hypertension, alongside one study looking to recruit Apabetalone users."
Has Apabetalone been given regulatory approval by the FDA?
"Given the available evidence, our team at Power has assigned Apabetalone a rating of 2 on its safety scale. This is because Phase 2 trials have yet to provide any data regarding efficacy; however there are preliminary indications that it can be taken safely."
What is the enrollment quota for this research study?
"This trial is no longer seeking participants. It first surfaced on October 1st 2022, with its last update taking place on April 22nd 2022. Meanwhile, those pursuing alternative studies can explore the 750 trials recruiting patients suffering from pulmonary arterial hypertension or the single study concerning Apabetalone currently enrolling individuals."
Are there any restrictions for individuals who wish to participate in this medical experiment?
"This pulmonary arterial hypertension study seeks 72 participants aged 18-75. Those wishing to participate must meet the following standards: PAH of idiopathic/hereditary/drug or toxin-induced origin; associated with connective tissue diseases or simple congenital heart disease (atrial septal defect, ventricular septal defect, patent ductus arteriosus) corrected for >1 year; WHO functional class II or III; Two 6MWD of ≥ 150m (the latter being used as baseline value); Patients must have a life expectancy ≥ 28 weeks.."
Is there an age restriction for participation in this trial, and if so, does it permit those aged 65 or more?
"Based on the trial's inclusion criteria, participants must be aged 18 or above and not exceed 75 years of age."
Is this new research pioneering in its field?
"Currently, the only ongoing trial for Apabetalone is found in a single country. This investigation was initiated by Resverlogix Corp in 2022 and has gone through its Phase 2 drug approval process with 72 patients. Since then, 18328 studies on this subject have already been conducted."
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