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

Hyperlipidemia Clinical Trial

— Prelip  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187757
• Other study ID #: Prelip/Nutra001/PMI13
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2014
• Last updated: May 14, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: PreEmptive Meds, Pvt. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Study Dietary Supplement (Prelipid 500 mg capsules)
Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.
• Placebo

Locations

Country	Name	City	State
India	Life Care Institute of Medical Science & Research	Ahmedabad	Gujarat
India	Pace Clinical Research Center	Bangalore	Tamil Nadu
India	Singvi Health Centre	Chennai	Tamil Nadu
India	Division of Clinical & Preventive Cardiology, Heart Institute	Gurgaon	Delhi
India	Fortis Escorts Hospital	Jaipur	Rajasthan
India	Bhatia Hospital Medical Research Society	Mumbai	Maharashtra
India	Dr. Vikas Govind Pai Clinical Research Foundation	Pune	Maharashtra
India	Rangammal Hospital	Tiruvannamalai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
PreEmptive Meds, Pvt. Ltd	Abbott

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function	Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)	Baseline (Day 1) to End of Study (Day 90)	Yes
Primary	Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels	Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days	Day 1 (Baseline) to Day 90 (End of Study)	No
Primary	Safety of Dietary Supplement PreLipid 600 mg twice-daily	Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)	Day 1(Baseline) to Day 90 (End of Study)	Yes
Secondary	Changes in Glycemic Status	To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.	Day 1 (Baseline) to Day 90 (End of Study)	Yes