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Cholesteryl Ester Transfer Protein (CETP) Inhibitor
Obicetrapib for Cardiovascular Disease (PREVAIL Trial)
Phase 3
Recruiting
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months after last participant randomized
Awards & highlights
PREVAIL Trial Summary
This trial will compare the effects of an experimental drug to a placebo in people with ASCVD who are not adequately controlled by current treatments. The study will be double-blind, meaning neither the patients nor the researchers will know who is receiving the experimental drug or the placebo.
Who is the study for?
This trial is for adults with cardiovascular disease who are already on the highest dose of cholesterol-lowering meds they can handle, but still have high LDL (bad) cholesterol. They should not be in advanced heart failure, have had recent serious heart events or cancer treatments, uncontrolled blood pressure, severe liver issues, or a history of substance abuse.Check my eligibility
What is being tested?
The study tests Obicetrapib against a placebo to see if it's better at managing cardiovascular risks when added to standard therapy. Participants won't know which one they're getting as it's randomly decided and kept secret even from the doctors (double-blind).See study design
What are the potential side effects?
While specific side effects for Obicetrapib aren't listed here, common ones for drugs like this include headache, muscle pain, digestive problems, and possible liver enzyme changes. Side effects vary by individual.
PREVAIL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months after last participant randomized
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months after last participant randomized
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Adverse Cardiovascular Effect (MACE)
PREVAIL Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: obicetrapib 10mgExperimental Treatment1 Intervention
one 10mg tablet, once daily.
Group II: PlaceboPlacebo Group1 Intervention
one placebo tablet, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Monash UniversityOTHER
187 Previous Clinical Trials
10,477,591 Total Patients Enrolled
NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
4,172 Total Patients Enrolled
Marc Ditmarsch, MDStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is severely reduced.I was hospitalized for heart failure in the last 5 years.I am 18 years old or older.My blood pressure is not controlled by medication.I have heart or blood vessel disease.I have been diagnosed with homozygous familial hypercholesterolemia.I have an ongoing liver condition.I have not taken gemfibrozil in the last 30 days.I had cancer surgery within the last 3 years.I am on the highest dose of medication for my cholesterol that I can tolerate.My kidney function is good, with a filtration rate of at least 30 mL/min.I haven't had a heart attack, stroke, or major heart procedure in the last 3 months.I have a brain blood vessel condition.I am 18 years old or older.Your cholesterol is too high when you haven't eaten for a while.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: obicetrapib 10mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Cardiovascular Disease Patient Testimony for trial: Trial Name: NCT05202509 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do numerous hospitals across America offer this research opportunity to patients?
"With locations in Lincoln, Hialeah and Dallas as well as an additional 94 sites, there is likely a clinical trial location near you. This study's organizers want to make participation as easy as possible, so please select the site that is most convenient for you."
Answered by AI
Has the FDA given Obicetrapib their stamp of approval?
"Obicetrapib, which is in Phase 3 of clinical trials, has received a safety score of 3 from our team at Power. This is because there is both some efficacy data and multiple rounds of supportive safety data."
Answered by AI
Is this research opportunity currently available to new participants?
"This is an active clinical trial that was first posted on February 7th, 2022 and updated November 2nd of the same year according to information found on clinicaltrials.gov"
Answered by AI
Who else is applying?
What state do they live in?
Other
British Columbia
Texas
California
How old are they?
18 - 65
What site did they apply to?
East Texas Cardiology, PA
Great Lakes Medical Research, LLC
Advanced Biomedical Research of America
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
3 attempts have been made to get past my left knee. Unsuccessful. Research for better medicine for condition to improve ones lifestyle while living it to the fullest.
PatientReceived 2+ prior treatments
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