Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified
Conditions
Interventions
Intervention1: FDC of Bempedoic Acid 180 mg + Atorvastatin 10 mg Tablets: Patients will be advised to take one tablet once a day orally, swallowed with water around same time every day for 12 weeks (8
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18 to 65 years (both inclusive) at the time of signing consent form. 2. Patients diagnosed with hypercholesterolemia are defined as: Low density lipoproteins - Cholesterol (LDL-C) levels greater than or equal to 100 mg per dL and less than or equal to 250 mg per dL. 3. Patients along with diet and exercise control additionally on the stable daily doses of Atorvastatin (10 mg or 20 mg or 40 mg respectively) at least 4 weeks prior to screening and having at least one of the following conditions. Heterozygous familial hypercholesterolemia AND OR Established atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. 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 end of study (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing, injection, transdermal patch or abstinence). 5. Patient with ability to understand and provide written, signed and dated informed consent form which must have been obtained prior to screening. 6. Patients are willing and able to comply with all the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 2. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 3. Patients with total fasting (minimum of 10 hours) triglycerides (TG) greater than or equal to 500 mg per dL at screening visit. 4. Patients with estimated glomerular filtration rate (eGFR) less than 30 mL per min per 1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening visit. 5. Patients with the body mass index (BMI) greater than or equal to 40 kg per m2 at screening visit. 6. Patients with uncontrolled hypertension defined as sitting systolic BP greater than or equal to 160 mmHg and or diastolic BP less than or equal to 100 mmHg at screening visit. 7. Patients with clinically significant impaired hepatic function (SGOT and SGPT greater than or equal to 3X the ULN and or Total bilirubin greater than or equal to 1.2X the ULN) at screening visit. 8. Patients with uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) greater than 1.5X the ULN at screening visit. Patients stabilized on thyroid replacement therapy for at least 6 weeks prior to randomization are allowed. 9. Patients with creatine kinase (CK) greater than 3X ULN at screening visit. 10. Patients with Type 1 diabetes at screening visit. 11. Patients with Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than or equal to 8%. 12. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III or IV, unstable or acute congestive heart failure. 13. Patients with recent or unstable cardiovascular disease: Any of the following within 90 days prior to screening, or currently unstable: acute coronary syndrome (STEMI or NSTEMI), unstable angina requiring urgent evaluation or hospitalization, coronary revascularization (PCI or CABG), ischemic stroke or TIA, hospitalization for decompensated heart failure, or a newly diagnosed or clinically significant arrhythmia requiring acute intervention. Note: Patients with established, clinically stable ASCVD greater than 90 days post-event or procedure, on stable background therapy, are eligible. 14. Patients with Gastrointestinal conditions or procedures (including weight loss surgery; or gastric bypass) that may affect drug absorption. 15. Patients with history of nephritic syndrome or nephritis at screening. 16. Patients with clinically significant gout within 3 months or symptomatic hyperuricemia at screening visit. 17. Patients who have a known history of tendon disorders or tendon rupture. 18. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient s participation in the study. 19. Patients with intolerance, contraindication or potential allergy or hypersensitivity to Bempedoic Acid or Atorvastatin or other similar class of study drugs. 20. Patients with a history of anaemia or haemoglobinopathy and or hemoglobin less than 10 g per dL for men; hemoglobin less than 9 g per dL for women at screening. 21. Patie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in low-density lipoproteins (LDL-C) from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in non-HDL-C and HDL-C from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3).;Percentage change in TC from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3).;Percentage change in apoB and hs-CRP from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3).;Absolute change in low density lipoproteins (LDL-C) from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3).;Adverse events and Serious adverse events reported during the study. Timepoint: Throughout the Study.;Changes in clinical laboratory parameters from baseline to end of the study visit (12 weeks).Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 5 - End of Study (EOS) visit or Week 12 (Day 85 3). | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed