A clinical study to assess the efficacy and safety of Bempedoic Acid Tablets in patients with high lipid levels and at high heart related risk.
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2021/10/037500
- Lead Sponsor
- Exemed Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 294
1. Male or Female patients aged between 18 to 75 (both inclusive) years.
2. Patient with Atherosclerotic Cardiovascular Disease (ASCVD) or Heterozygous Familial Hypercholesterolemia (HeFH) or both:
- Have ASCVD [with established Coronary Heart Disease (CHD) or CHD risk equivalents] > 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 (e.g., 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 <0.9 performed by a vascular lab or
- angiogram (including computed tomographic angiography [CTA]) showing �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.
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.
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 ability to understand and provide written informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with all the protocol related 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) <30 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. 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 (e.g., 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.
10. Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
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 Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
14. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
15. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
16. 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).
17. Patients with history of any malignancy.
18. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
19. Patients with Hyperuricemia.
20. Patients who have a history of tendon disorders or tendon rupture.
21. Patients with donation or transfusion of blood, plasma, or platelets within the past 30 days prior to screening.
22. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patientââ?¬•s participation in the study.
23. Patients with concurrent participation in another clinical trial within 90 days prior to signing informed consent.
24. Patients cur
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline to Week 12 in LDL-C.Timepoint: Week 12
- Secondary Outcome Measures
Name Time Method Absolute change from baseline to Week 12 in LDL-C.Timepoint: Week 12;Adverse events / Serious adverse events reported during the study.Timepoint: Week 4, Week 8 and Week 12;Changes in clinical laboratory parameters from baseline to end of the study visit (Week 12).Timepoint: Baseline and Week 12;Percent change from baseline to Week 12 in non-HDL-C, TC, apoB, and hs-CRP.Timepoint: Week 12