Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels

Not Applicable

• Conditions: Health Condition 1: null- Patients with higher LDL-C (Low Density Lipoprotein- Cholestrol)then normal value

• Registration Number: CTRI/2014/10/005077
• Lead Sponsor: Preemptive Meds Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:

Age >= 18 years to <= 65 years

ï??LDL cholesterol levels >140mg/dl but <190mg/dl CHD)

ï??Participants who are on Atorvastatin 10 mg daily treatment with life style modification program for at least last 03 months and have LDL-C i.e >140 mg/dl with 0-2 risk factor

ï??Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures

Exclusion Criteria

ï??Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.

ï??Cardiac status New York Heart Association class III-IV

ï??Uncotrolled blood pressure 150 mmhg systolic and 100 mmhg diastolic

ï??Impaired renal function as shown by but not limited to serum creatinine >= 1.5 mg/dl for males and >= 1.4 mg/dl for female

ï??Clinically significant peripheral edema

ï??Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)

ï??Participants on steroid

ï??Pregnancy or lactating women

ï??Known hypersensitivity to any of the study drugs

ï??Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.

ï??Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years

ï??Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

ï??Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study

ï??Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study evaluation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified