HyperlipidemiaPhase 3PrelipNCT02187757
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels
A Phase 3 study testing Study Dietary Supplement (Prelipid 500 mg capsules) in people with Hyperlipidemia, run by PreEmptive Meds, Pvt. Ltd at 8 sites in India.
Trial summary
Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Study Dietary Supplement (Prelipid 500 mg capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 8 sitesIndia
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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)
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- 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.
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Life Care Institute of Medical Science & Research
Ahmedabad, Gujarat, 380014
Pace Clinical Research Center
Bangalore, Tamil Nadu, 560043
Singvi Health Centre
Chennai, Tamil Nadu, 600079
Division of Clinical & Preventive Cardiology, Heart Institute
Gurgaon, National Capital Territory of Delhi, 122001
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017
Bhatia Hospital Medical Research Society
Mumbai, Maharashtra, 400007
Dr. Vikas Govind Pai Clinical Research Foundation
Pune, Maharashtra, 411005
Rangammal Hospital
Tiruvannamalai, Tamil Nadu, 606003
About this study
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 to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels
Read the 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
- Conditions
- Hyperlipidemia
- Being tested
- Study Dietary Supplement (Prelipid 500 mg capsules), Placebo
- Keywords
- Dyslipidemia, High cholesterol, High LDL, Triglycerides
- Medical subject headings
- Hyperlipidemias, Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Dietary Supplement (Prelipid 500 mg capsules)Dietary supplement
Also called PreLipid, Natural Cholesterol Supplement, Predisease
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.
PlaceboDietary supplement
Also called Placebo 600 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Day 1(Baseline) to Day 90 (End of Study)
Secondary outcomes (1)
Changes in Glycemic Status
To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months.
Measured: Day 1 (Baseline) to Day 90 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- PreEmptive Meds, Pvt. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Joe Fenn, Medanta, The Medicity, India
- Investigators
- Ravi Kasliwal, MD, DM, FIMSA, Study chair, Medanta, The Medicity, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187757
- Sponsor's protocol ID
- Prelip/Nutra001/PMI13
- Acronym
- Prelip
- Status last verified
- May 2015
- First submitted
- 30 Jun 2014
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02187757
- Acronym / sponsor ID
- Prelip / Prelip/Nutra001/PMI13
- Conditions
- Hyperlipidemia
- Keywords
- Dyslipidemia, High cholesterol, High LDL, Triglycerides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- PreEmptive Meds, Pvt. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PreLipid | Experimental | 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 90days along with lifestyle modification. |
| Placebo 600 mg capsules | Placebo comparator | Dietary Supplement: PlaceboPlacebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Dietary Supplement (Prelipid 500 mg capsules)Also: PreLipid, Natural Cholesterol Supplement, PrediseaseStudy Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification. | Dietary supplement | PreLipid |
| PlaceboAlso: Placebo 600 mg capsules | Dietary supplement | Placebo 600 mg capsules |
Primary outcome
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)
Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days
Safety of Dietary Supplement PreLipid 600 mg twice-daily
Time frame: Day 1(Baseline) to Day 90 (End of Study)
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)
1 secondary outcome
Changes in Glycemic Status
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Kasliwal, MD, DM, FIMSA study chair
Medanta, The Medicity, India
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Study Dietary Supplement (Prelipid 500 mg capsules) in people with Hyperlipidemia, run by PreEmptive Meds, Pvt. Ltd at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.