Status:
COMPLETED
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels
Lead Sponsor:
PreEmptive Meds, Pvt. Ltd
Collaborating Sponsors:
Abbott
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels
Detailed Description
A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with h...
Eligibility Criteria
Inclusion
- 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
- LDL cholesterol levels \>120mg/dl
- 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
- Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
- Cardiac status New York Heart Association class III-IV
- Uncotrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
- 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
- Clinically significant peripheral edema
- 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)
- Participants on steroid
- Pregnancy or lactating women
- Known hypersensitivity to any of the study drugs
- 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.
- Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
- 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
- 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
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.
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Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT02187757
Start Date
November 1 2013
End Date
November 1 2014
Last Update
May 15 2015
Active Locations (8)
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1
Life Care Institute of Medical Science & Research
Ahmedabad, Gujarat, India, 380014
2
Bhatia Hospital Medical Research Society
Mumbai, Maharashtra, India, 400007
3
Dr. Vikas Govind Pai Clinical Research Foundation
Pune, Maharashtra, India, 411005
4
Division of Clinical & Preventive Cardiology, Heart Institute
Gurgaon, National Capital Territory of Delhi, India, 122001