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

NCT02187757 | Completed Phase 3 DMC

• 1 other identifier: Prelip/Nutra001/PMI13
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Hyperlipidemia

Keywords

Dyslipidemia; High cholesterol; High LDL; Triglycerides

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (1)

• Changes in Glycemic Status

  Day 1 (Baseline) to Day 90 (End of Study)

Other Outcomes (1)

• Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function

  Baseline (Day 1) to End of Study (Day 90)

Study Arms (2)

PreLipid

EXPERIMENTAL

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

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

Placebo 600 mg capsules

PLACEBO COMPARATOR

Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Dietary Supplement: Placebo

Interventions

Study Dietary Supplement (Prelipid 500 mg capsules) DIETARY_SUPPLEMENT

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.

Also known as: PreLipid, Natural Cholesterol Supplement, Predisease

PreLipid

Placebo DIETARY_SUPPLEMENT

Also known as: Placebo 600 mg capsules

Placebo 600 mg capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• PreEmptive Meds, Pvt. Ltd: lead
• Abbott: collaborator

Study Sites (8)

Life Care Institute of Medical Science & Research

Ahmedabad, Gujarat, 380014, India

Location

Bhatia Hospital Medical Research Society

Mumbai, Maharashtra, 400007, India

Location

Dr. Vikas Govind Pai Clinical Research Foundation

Pune, Maharashtra, 411005, India

Location

Division of Clinical & Preventive Cardiology, Heart Institute

Gurgaon, National Capital Territory of Delhi, 122001, India

Location

Fortis Escorts Hospital

Jaipur, Rajasthan, 302017, India

Location

Pace Clinical Research Center

Bangalore, Tamil Nadu, 560043, India

Location

Singvi Health Centre

Chennai, Tamil Nadu, 600079, India

Location

Rangammal Hospital

Tiruvannamalai, Tamil Nadu, 606003, India

Location

MeSH Terms

Conditions

Hyperlipidemias; Dyslipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ravi Kasliwal, MD, DM, FIMSA

  Medanta, The Medicity, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Clinical & Preventive Cardiology

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 11, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

IN (8)