Clinical trial NCT02187757: Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels
Official title: 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 Higher Than Normal Blood Lipid Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Dyslipidemia
High cholesterol
High LDL
Triglycerides
Lead sponsor: PreEmptive Meds, Pvt. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2014-07-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 higher than normal blood lipid levels

Eligibility criteria: 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:

1. Age ≥ 18 years to ≤ 65 years
2. LDL cholesterol levels \>120mg/dl
3. 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:

1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
2. Cardiac status New York Heart Association class III-IV
3. Uncotrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
4. 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
5. Clinically significant peripheral edema
6. 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)
7. Participants on steroid
8. Pregnancy or lactating women
9. Known hypersensitivity to any of the study drugs
10. 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.
11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
12. 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
13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study
15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.

    -

Primary outcomes:
measure: Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels
timeFrame: Day 1 (Baseline) to Day 90 (End of Study)
measure: Safety of Dietary Supplement PreLipid 600 mg twice-daily
timeFrame: Day 1(Baseline) to Day 90 (End of Study)
Secondary outcomes:
measure: Changes in Glycemic Status
timeFrame: Day 1 (Baseline) to Day 90 (End of Study)
Other outcomes:
measure: Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function
timeFrame: Baseline (Day 1) to End of Study (Day 90)
Locations:
city: Gurgaon
country: India
facility: Division of Clinical & Preventive Cardiology, Heart Institute
state: Delhi
city: Ahmedabad
country: India
facility: Life Care Institute of Medical Science & Research
state: Gujarat
city: Mumbai
country: India
facility: Bhatia Hospital Medical Research Society
state: Maharashtra
city: Pune
country: India
facility: Dr. Vikas Govind Pai Clinical Research Foundation
state: Maharashtra
city: Jaipur
country: India
facility: Fortis Escorts Hospital
state: Rajasthan
city: Bangalore
country: India
facility: Pace Clinical Research Center
state: Tamil Nadu
city: Chennai
country: India
facility: Singvi Health Centre
state: Tamil Nadu
city: Tiruvannamalai
country: India
facility: Rangammal Hospital
state: Tamil Nadu
Study officials:
affiliation: Medanta, The Medicity, India
name: Ravi Kasliwal, MD, DM, FIMSA
role: STUDY_CHAIR
References: