Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02187757
• Date of registration: 30/06/2014
• Prospective Registration: No
• Primary sponsor: PreEmptive Meds, Pvt. Ltd
• Public title: Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels Prelip
• Scientific 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
• Date of first enrolment: November 2013
• Target sample size: 180
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02187757
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Ravi Kasliwal, MD, DM, FIMSA
• Affiliation: Medanta, The Medicity, India

Key inclusion & exclusion 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.

-



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperlipidemia

Intervention(s)

Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)

Dietary Supplement: Placebo

Primary Outcome(s)

Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels [Time Frame: Day 1 (Baseline) to Day 90 (End of Study)]

Safety of Dietary Supplement PreLipid 600 mg twice-daily [Time Frame: Day 1(Baseline) to Day 90 (End of Study)]

Secondary Outcome(s)

Changes in Glycemic Status [Time Frame: Day 1 (Baseline) to Day 90 (End of Study)]

Secondary ID(s)

Prelip/Nutra001/PMI13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott