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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02993406




Registration number
NCT02993406
Ethics application status
Date submitted
9/12/2016
Date registered
15/12/2016

Titles & IDs
Public title
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
Secondary ID [1] 0 0
1002-043
Universal Trial Number (UTN)
Trial acronym
CLEAR Outcomes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Statin Adverse Reaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bempedoic acid 180 mg tablet
Treatment: Drugs - Matching placebo tablet

Experimental: Bempedoic Acid 180 mg - Bempedoic acid 180 mg tablet taken orally, once daily.

Placebo comparator: Placebo Comparator - Matching placebo tablet taken orally, once daily


Treatment: Drugs: Bempedoic acid 180 mg tablet
Patients take bempedoic acid 180 mg tablet orally once daily

Treatment: Drugs: Matching placebo tablet
Patients take matching placebo tablet orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
Timepoint [1] 0 0
Up to 68 months
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of Three Component MACE
Timepoint [1] 0 0
Up to 68 months
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of Myocardial Infarction
Timepoint [2] 0 0
Up to 68 months
Secondary outcome [3] 0 0
Number of Participants With Time to First Occurrence of Coronary Revascularization
Timepoint [3] 0 0
Up to 68 months
Secondary outcome [4] 0 0
Number of Participants With Time to First Occurrence of Stroke
Timepoint [4] 0 0
Up to 68 months
Secondary outcome [5] 0 0
Number of Participants With Time to Cardiovascular Death
Timepoint [5] 0 0
Up to 68 months
Secondary outcome [6] 0 0
Number of Participants With Time to All-cause Mortality
Timepoint [6] 0 0
Up to 68 months

Eligibility
Key inclusion criteria
* Age between 18 and 85 years
* History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
* Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:

* 2 or more statins at any dose, or
* 1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.

Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.

* Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
* Men and nonpregnant, nonlactating women
* Fasting blood LDL-cholesterol = 100 (2.6 mmol/L) at screening
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
* Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
* History of severe heart failure
* Uncontrolled hypertension or uncontrolled diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/11/2022
Sample size
Target
Accrual to date
Final
13970
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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- Adamstown
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- Camperdown
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- Gosford
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- Liverpool
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- Merewether
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- Tumbi Umbi
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- Wollongong
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- Auchenflower
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- Bundaberg
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- Chermside
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- Milton
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- Sherwood
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- Sippy Downs
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- Woolloongabba
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- Adelaide
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- Ashford
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- Langwarrin
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- Melbourne
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- Mildura
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- Joondalup
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- Murdoch
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- Nedlands
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- Perth
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- Subiaco
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2289 - Adamstown
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2050 - Camperdown
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2250 - Gosford
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2170 - Liverpool
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4066 - Auchenflower
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4670 - Bundaberg
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4032 - Chermside
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4556 - Sippy Downs
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5063 - Fullarton
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3350 - Ballarat
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3199 - Frankston
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3910 - Langwarrin
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3004 - Melbourne
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3500 - Mildura
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6027 - Joondalup
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6150 - Murdoch
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6009 - Nedlands
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6000 - Perth
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6008 - Subiaco
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Germany
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Germany
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Germany
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Germany
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Hungary
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Hungary
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Poland
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Chelm
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Poland
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Poland
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Poland
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Poland
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Poland
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Zalau
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Russian Federation
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Altayskiy Kray
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Arkhangelsk
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Russian Federation
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Kazan
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Russian Federation
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Russian Federation
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Russian Federation
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Kirov
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Perm
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Serbia
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Serbia
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Serbia
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Užice
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Serbia
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Zajecar
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Northumberland
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Somerset
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Yorkshire
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Chesterfield
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Crownhill
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Whitby

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Esperion Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02993406