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Bempedoic acid 180 mg tablet for Cardiovascular Disease (CLEAR Outcomes Trial)

Phase 3

Waitlist Available

Research Sponsored by Esperion Therapeutics, Inc.

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 up to 68 months

Awards & highlights

CLEAR Outcomes Trial Summary

This trial will test if bempedoic acid can help people who can't tolerate statins by reducing their risk of cardiovascular events.

Eligible Conditions

Cardiovascular Disease
Statin Adverse Reaction Syndrome

CLEAR Outcomes Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 68 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 68 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)

Secondary outcome measures

Number of Participants With First Occurrence of Myocardial Infarction

Number of Participants With First Occurrence of Three Component MACE

Number of Participants With Time to All-cause Mortality

+3 more

Side effects data

From 2022 Phase 3 trial • 13970 Patients • NCT02993406

11%

Hyperuricaemia

11%

Hypertension

10%

COVID-19

Urinary tract infection

Arthralgia

Diabetes mellitus

Headache

Blood uric acid increased

Myalgia

Back pain

Nasopharyngitis

Cholelithiasis

Pneumonia

Angina pectoris

Non-cardiac chest pain

Osteoarthritis

COVID-19 pneumonia

Angina unstable

Cardiac failure congestive

Transient ischaemic attack

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Bempedoic Acid 180 mg

Placebo Comparator

CLEAR Outcomes Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bempedoic Acid 180 mgExperimental Treatment1 Intervention

Bempedoic acid 180 mg tablet taken orally, once daily.

Group II: Placebo ComparatorPlacebo Group1 Intervention

Matching placebo tablet taken orally, once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bempedoic acid

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Esperion Therapeutics, Inc.Lead Sponsor

25 Previous Clinical Trials

7,948 Total Patients Enrolled

The Cleveland ClinicOTHER

1,028 Previous Clinical Trials

1,350,508 Total Patients Enrolled

Michael Louie, MDStudy DirectorEsperion Therapeutics, Inc.

2 Previous Clinical Trials

74 Total Patients Enrolled

Frequently Asked Questions

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

Are there precedent cases for Bempedoic acid 180 mg tablet efficacy?

"The first clinical trial involving bempedoic acid 180 mg tablets was completed in 2016 (NCT02993406). There have been 20 such studies in total. Currently, 1 clinical study is active with a notable location being Rockville, Maryland."

Answered by AI

Will lenalidomide help patients who are young adults?

"In order to participate in this particular trial, patients must be between 18-85 years old. For perspective, there are 28 trials for people who are under the age of 18 and 391 trials for those that are over 65."

Answered by AI

Is this trial being administered in multiple locations across the state?

"Enrollment for this study is currently open at 100 different sites. While Rockville, Miami and North Miami Beach are some of the locations, there are also many other options closer to where potential patients might live. To limit undue travel burdens, please select the location nearest you."

Answered by AI

What is Bempedoic acid 180 mg tablet's main purpose?

"Bempedoic acid 180 mg tablet is an effective medication for patients that require LDL-C lowering, in addition to those with diet-, hypercholesterolemia-, and atherosclerotic cardiovascular disease-related conditions."

Answered by AI

What verdict did the FDA come to regarding Bempedoic acid 180 mg tablet?

"There is both efficacy and safety data supporting Bempedoic acid 180 mg tablet, which gives it a score of 3."

Answered by AI

Does this medical experiment pave the way for other similar treatments?

"Bempedoic acid 180 mg tablet has been researched since 2016. The earliest study, which was sponsored by Esperion Therapeutics, Inc., occurred in 2016 and involved 14014 participants. Following the completion of the Phase 3 drug approval stage, there is now a single active study for Bempedoic acid 180 mg tablet being conducted by Esperion Therapeutics, Inc.."

Answered by AI

What are the eligibility requirements to participate in this clinical trial?

"This study, which will enroll a total of 14014 patients, is seeking individuals that have cardiovascular diseases and are between 18 and 85 years old."

Answered by AI