Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Bempedoic Acid Tablets 180 mg along with Matching placebo of reference: The recommended dosage of Bempedoic acid, in combination with maximally tolerated statin therapy is 180 mg admini
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patient of either gender, aged between 18 and 75 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening. 2) Patient with ASCVD or Heterozygous Familial Hypercholesterolemia (HeFH) or both: -Have ASCVD (with established CHD or CHD risk equivalents) more than 3 months prior to screening Documented history of CHD (includes 1 or more of the following): >Acute MI >Silent MI >Unstable angina >Coronary revascularization procedure (eg, percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) >Clinically significant CHD diagnosed by invasive or non-invasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography, or nuclear imaging) Documented CHD risk equivalents (includes 1 or more of the following criteria): >Symptomatic peripheral arterial disease (PAD) defined as > >peripheral vascular disease with symptoms of claudication or resting limb ischemia with either ankle brachial index less than 0.9 performed by a vascular lab OR > >angiogram (including computed tomographic angiography [CTA]) showing more than equal to 50% stenosis OR > >peripheral arterial revascularization (surgical or percutaneous) occurring greater than 90 days prior to Screening visit OR > >abdominal aortic aneurysm confirmed by imaging or aortic aneurysm repair occurring greater than 90 days prior to Screening visit OR > >lower extremity amputation due to peripheral vascular disease occurring greater than 90 days prior to Screening visit >Cerebrovascular atherosclerotic disease defined by: > >ischemic stroke occurring greater than 90 days prior to Screening visit OR > >Carotid endarterectomy, carotid stenting, or more than 70% stenosis in a carotid artery determined by carotid ultrasound or angiogram occurring greater than 90 days prior to Screening visit. Note: Patients with T2DM are allowed in this study; however, for this study T2DM is not considered a CHD risk equivalent. -Diagnosis of HeFH: Diagnosis must be made by either genotyping or by clinical assessment using Dutch Lipid Clinical Network Criteria with a score that is more than 5 points. 3) Patients who are not able to achieve less than 70 mg/dl level of LDL-C despite being on 40 mg of Rosuvastatin or 80 mg of Atorvastatin for at least 6 weeks prior to screening. 4) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence). [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natura
Exclusion criteria
Exclusion criteria: 1. Patient with Total fasting (minimum of 10 hours) TG more than equal to 500 mg/dL at screening (Note: TG may be repeated one time during screening period. For those patients who have a repeat TG, the repeat value will be used to determine eligibility. 2. Patient with Renal impairment (eGFR less than 30 mL/min/1.73 m2) or nephritic syndrome or a history of nephritis at screening. 3. Patient with Body mass index (BMI) more than equal to 40 kg/m2 at screening 4. Patient with recent (within 3 months prior to the screening visit) uncontrolled or symptomatic cardiac arrhythmia (or medication for an arrhythmia that was started or dose changed within 3 months of screening), transient ischemic attack (TIA) OR plans to undergo a major surgical or interventional procedure (eg, PCI, CABG, carotid or peripheral revascularization) during study. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months from screening. 5. Patient with Uncontrolled hypertension, defined as sitting systolic blood pressure (SBP) more than equal to 160 mmHg and diastolic blood pressure (DBP) more than equal to 100 mmHg after sitting quietly for 5 minutes. Note: If the initial blood pressure (BP) values meet or exceed the specified level, an additional BP assessment may be performed. If the systolic or the diastolic values continue to meet or exceed the threshold, the patient will be excluded. 6. Patient with Hemoglobin A1C (HbA1C) more than equal to 9 % at Screening visit 7. Patient with Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) more than 1.5 × the upper limit of normal (ULN) at Screening visit. Patients stabilized on thyroid replacement therapy for at least 6 weeks prior to randomization are allowed. 8. Patient with Liver disease or dysfunction, including: -Alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than equal to 2 × ULN, and/or total bilirubin (TB) more than equal to 2 × ULN at screening visit. Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be performed prior to randomization. For those patients who have a repeat ALT and/or AST, the repeat value will be used to determine eligibility. 9. Patient with history of HIV or hepatitis B or hepatitis C at screening visit. 10. Patient with Gastrointestinal conditions or procedures (including weight loss surgery; or gastric bypass) that may affect drug absorption 11. Patient with Hematologic or coagulation disorders or a hemoglobin (Hgb) level less than 9.0 g/dL (90 g/L) at Screening visit 12. Patient with Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed 13. Patient with history of tendon disorders or tendon rupture 14. Patient with creatine kinase (CK) more than 3 × ULN at screening 15. Patient with current diagnosis of substance abuse (as per DSM-5) or history of alcohol or drug abuse in the past 3 months prior to screening visit 16. Patient with Blood donation, blood transfusion, participation in a clinical study with multiple blood draws, major trauma, or surgery with or without blood loss within 30 days prior to randomization <br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Week 12 in LDL-CTimepoint: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change from baseline to Week 12 in LDL-CTimepoint: week 12;• Safety evaluation, as measured by TEAEs, Adverse Reactions (ARs), SAEs, Serious ARsTimepoint: 12 weeks;Percent change from baseline to Week 12 in non-HDL-C, TC, apoB, and hs-CRPTimepoint: week 12 | — |
Countries
India
Contacts
Public ContactSucheta Pandit
Sun Pharma laboratories Limited
Outcome results
None listed