Health Condition 1: E780- Pure hypercholesterolemia
Conditions
Interventions
Intervention1: Arteroclez Syrup 10ml along with standard of care: Pateints will receive Arteroclez Syrup 10 ml twice daily for 24 weeks
Control Intervention1: Placebo along with standard of care: Pate
Sponsors
MONTOSUN BIOPHARMA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Male or female participants aged 30 to 70 years inclusive Presence of measurable carotid atherosclerotic plaque detected by carotid ultrasound at screening or baseline Participants must be planned to receive Standard of Care SOC and must be willing to continue SOC throughout the study duration Participants at risk for coronary artery disease defined by the presence of at least one of the following Low density lipoprotein cholesterol LDL C greater than or equal to 130 mg dL and less than or equal to 190 mg dL Total cholesterol greater than or equal to 200 mg dL Family history of premature coronary artery disease Hypertension controlled or untreated Overweight or obesity BMI greater than or equal to 23 kg m square as per Asian Indian criteria Prediabetes or controlled type 2 diabetes mellitus HbA1c less than or equal to 75 percent On stable standard of care therapy lifestyle modification with or without statin or other lipid lowering therapy for at least 8 to 12 weeks prior to randomization Evidence of carotid intima media thickness CIMT elevation along with carotid atherosclerotic plaque detected by carotid ultrasound at baseline Willing and able to maintain a stable diet and physical activity level throughout the study period Ability and willingness to provide written informed consent prior to participation in any study related procedures Participants both males and females of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose of study treatment
Exclusion criteria
Exclusion criteria: History of established atherosclerotic cardiovascular disease including myocardial infarction coronary revascularization percutaneous coronary intervention PCI or coronary artery bypass grafting CABG stroke or transient ischemic attack Severe hypercholesterolemia LDL C greater than 190 mg dL requiring intensive or aggressive lipid lowering therapy Uncontrolled hypertension defined as systolic blood pressure SBP greater than or equal to 160 mmHg or diastolic blood pressure DBP greater than or equal to 100 mmHg at screening Uncontrolled diabetes mellitus HbA1c greater than 75 to 80 percent as per investigator judgment or protocol defined threshold Clinically significant hepatic impairment defined as alanine aminotransferase ALT or aspartate aminotransferase AST greater than 2 times the upper limit of normal ULN Clinically significant renal impairment defined as estimated glomerular filtration rate eGFR less than 60 mL min 173 m square Use of nutraceuticals herbal products or dietary supplements with known lipid lowering or antiatherosclerotic effects within 4 weeks prior to screening Known hypersensitivity or intolerance to any component of the investigational product Arteroclez Syrup 10 ML Pregnant or lactating women or women of childbearing potential planning pregnancy during the study period Participation in another interventional clinical trial within 3 months prior to screening Any medical condition or circumstance that in the opinion of the investigator could interfere with study participation compromise participant safety or affect the integrity of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in atherosclerotic plaque burden, measured as Total Carotid Plaque Area TPA using carotid ultrasound B-mode imagingTimepoint: from baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in low-density lipoprotein cholesterol Change in total cholesterol triglycerides and high density lipoprotein cholesterol Proportion of participants achieving LDL C target levels less than 100 mg per dL Change in high-sensitivity C reactive protein Change in systolic and diastolic blood pressure Change in body weight body mass index and waist circumference Change in fasting blood glucose and glycated hemoglobin HbA1c Timepoint: from baseline to Weeks 12 and 24 | — |
Countries
India
Contacts
Public ContactChandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed