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Clinical Trials/EUCTR2016-004084-39-CZ
EUCTR2016-004084-39-CZ
Active, not recruiting
Phase 1

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C on Low Dose or Less than Low Dose Statins

Esperion Therapeutics Inc.,0 sites225 target enrollmentApril 3, 2017
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ConditionsThis study is to assess the efficacy of bempedoic acid 180 mg/day versus placebo in decreasing low-density lipoprotein cholesterol (LDL-C) when added to ezetimibe therapy in patients with high LDL-Cholesterol on Low Dose or Less than Low Dose Statins.MedDRA version: 20.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsEzetrol®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
This study is to assess the efficacy of bempedoic acid 180 mg/day versus placebo in decreasing low-density lipoprotein cholesterol (LDL-C) when added to ezetimibe therapy in patients with high LDL-Cholesterol on Low Dose or Less than Low Dose Statins.
Sponsor
Esperion Therapeutics Inc.,
Enrollment
225
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 3, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Esperion Therapeutics Inc.,

Eligibility Criteria

Inclusion Criteria

  • •Each potential patient must satisfy all inclusion criteria to be enrolled in the study. Selected inclusion criteria are listed below; all inclusion criteria are listed in the protocol body.
  • •1\. Provision of written informed consent prior to any study\-specific procedure
  • •2\. Age \=18 years or legal age of majority based on regional law, whichever is greater, at Week \-5 (Visit S1\)
  • •3\. Fasting (minimum of 10 hours) calculated LDL\-C at Week \-5 (Visit S1\) as defined by ezetimibe use at screening:
  • •For patients who have been taking ezetimibe 10 mg daily prior to Week \-5 (Visit S1\): Fasting LDL\-C \=100 mg/dL (2\.6 mmol/L) on stable background lipid\-modifying therapy (LMT; greater than or equal to 4 weeks prior to screening).
  • •For patients who have not been taking ezetimibe Week \-5 (Visit S1\): Fasting LDL\-C \=120 mg/dL (3\.1 mmol/L) on stable background LMT (greater than or equal to 4 weeks prior to screening).
  • •All patients must have fasting LDL\-C \=70 mg/dL (1\.8 mmol/L) at Week \-1 (Visit S3\).
  • •4\. Currently receiving stable (greater than or equal to 4 weeks prior to screening) background statin dose that does not exceed low dose statin therapy.
  • •Note: Patients must report attempting greater than low dose statin therapy and being unable to tolerate it due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or the dose lowered. Low dose statin therapy is defined as
  • •an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg,

Exclusion Criteria

  • •1\. BMI \>50 kg/m2
  • •2\. Recent history of documented clinically significant cardiovascular disease including, but not limited to
  • •Within 3 months of screening, (Week \-5 \[Visit S1]) or between
  • •screening and randomization, MI, severe/unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, cerebrovascular event, symptomatic carotid artery disease, or symptomatic peripheral arterial disease
  • •Uncontrolled hypertension
  • •Within 3 months of screening (Week \-5 \[Visit S1]) or between
  • •screening and randomization visits, an arrhythmia requiring medical intervention
  • •Planned revascularization procedures
  • •New York Heart Association (NYHA) Class IV heart failure
  • •3\. Total fasting (minimum of 10 hours) TG \=500 mg/dL (5\.6 mmol/L) at Week \-5 (S1\)

Outcomes

Primary Outcomes

Not specified

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