A study to assess the efficacy and safety of Bempedoic Acid and Rosuvastatin Tablets in patients with lipid diorder.
- Conditions
- Health Condition 1: E780- Pure hypercholesterolemia
- Registration Number
- CTRI/2023/09/057946
- Lead Sponsor
- Exemed Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients aged between 18 to 65 years (both inclusive).
2. Patients diagnosed with hypercholesterolemia defined as: LDL-C levels = 100 mg/dL and = 250 mg/dL.
3. Patients who are not able to tolerate the dosage of Rosuvastatin more than 20 mg.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
5. Patients with no abnormality on 12-lead ECG at screening / baseline visit.
6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
7. Patients willing to comply with the protocol requirements.
1. Patients with total fasting (minimum of 10 hours) triglycerides (TG) = 500 mg/dL at screening visit.
2. Patients with estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening visit.
3. Patients with the Body Mass Index (BMI) = 40 kg/m2 at screening visit.
4. Patients with uncontrolled hypertension defined as sitting systolic BP = 160 mmHg and/or diastolic BP = 100 mmHg at screening visit.
5. Patients with clinically significant impaired hepatic function (SGOT & SGPT = 2X the UNL and/or Total bilirubin = 1.2X the UNL) at screening visit.
6. Patients with uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5X the ULN at screening visit. Patients stabilized on thyroid replacement therapy for at least 6 weeks prior to randomization are allowed.
7. Patients with creatine kinase (CK) >3X ULN at screening visit.
8. Patients with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value = 9%.
9. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
10. Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
11. Patient with Gastrointestinal conditions or procedures (including weight loss surgery; or gastric bypass) that may affect drug absorption.
12. Patients with history of nephritic syndrome or nephritis at screening.
13. Patients with history of hyperuricemia.
14. Patients who have a history of tendon disorders or tendon rupture.
15. 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.
16. Patients with intolerance, contraindication or potential allergy/hypersensitivity to Bempedoic Acid or Ezetimibe or statins or other similar class of study drugs.
17. Patients with a history of anaemia or haemoglobinopathy and/or hemoglobin < 10 g/dL for men; hemoglobin < 9 g/dL for women at screening.
18. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
19. 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).
20. Patients with history of any malignancy.
21. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
22. Patients with donation or transfusion of blood, plasma, or platelets within the past 30 days prior to screening.
23. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
24. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
25. Patients currently taking any of the prohibited medications(s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in low-density lipoproteins (LDL-C) from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).
- Secondary Outcome Measures
Name Time Method Absolute change in low density lipoproteins (LDL-C) from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).;Adverse events & serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).;Percentage change in HDL-C from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).;Percentage change in non-HDL-C from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).;Percentage change in TC from baseline to end of the study.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Week 12).