Mixed HyperlipoproteinemiaPhase 4PrOteCTNCT02069106
Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction
A Phase 4 study testing Pro-Omega LDL in people with Mixed Hyperlipoproteinemia, run by Nordic Pharma, USA.
Trial summary
Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Hyperlipoproteinemia
- What is being tested?
- Pro-Omega LDL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, ≥18 years of age.
- History (>3months) of LDL-C ≥130 mg/dl to ≤190 mg/dL
- Triglycerides (TG) > 200 to <750 mg/dL
- Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
- Willing to maintain a stable diet and level of activity throughout the trial. Willing to maintain current activity level and diet throughout the trial.
- If, of childbearing age, must be on a medically approved form of birth control as identified by the investigator in this trial
- History (> 3 months) of taking a statin medication (HMG-CoA reductase inhibitor, including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) without problems, and would be willing to withdraw from statin for the duration of the trial (4 weeks without statin prior to randomization for washout period, then treatment with protocol medication for 10 week duration of the trial)
Who cannot join
- Individuals with intolerance of, or allergy to red yeast rice or omega 3 fatty acids.
- Individuals currently taking a statin (HMG-CoA Reductase inhibitor) including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) or other lipid metabolism altering product within four (4) weeks prior to randomization who do not wish to withdraw from therapy.
- Individual taking prescription or over the counter medications (including dietary supplements) known to alter lipid metabolism within four (4) weeks of randomization. Medications excluded within 4 weeks of randomization are: prescription omega-3 fatty acids, statins, bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates. Dietary supplements excluded within 4 weeks prior to randomization are: L-carnitine, policosanol, guggulipid, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues, probiotics and dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplements per day and prebiotics), or any dietary supplement or vitamin complex product containing omega 3 acids or fish oil.
- Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment).
- Use of the anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto).
- Pregnant or lactating women, or women of childbearing potential who are not complying with an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, one or more years postmenopausal, or one or more years post-tubal ligation.
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- Individuals with a history of myopathy, defined as a creatine phosphokinase (CPK) >450 U/L and/or unexplained muscle pain on statins.
- Type I or type II diabetes mellitus or HbA1c ≥7.0%
- History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction.
- Current or recent (within six months) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease
- History of cancer, other than non-melanoma skin cancer and basal cell carcinoma, within the previous five years.
- Poorly controlled or uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥95 mm Hg).
- Recent history (within past 6 months) of excessive alcohol use, defined as >14 drinks per week (One drink = 12 oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
- Exposure to any investigational agent within 4 weeks prior to Visit 1.
- Has a condition the Investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study.
About this study
Official title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction in Subjects With Mixed Hyperlipoproteinemia
Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia.
- Conditions
- Mixed Hyperlipoproteinemia
- Being tested
- Pro-Omega LDL, Placebo
- Keywords
- low density lipoprotein cholesterol, triglycerides, mixed hyperlipoproteinemia, Dehydroascorbic Acid, Eicosapentaenoic Acid, Fish oil
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-Omega LDLDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Pro-Omega LDL | Experimental | 3 capsules 1000 mg BID for 8 weeks Receives: Dietary Supplement: Pro-Omega LDL |
| Placebo | Placebo comparator | 3 capsules BID for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-density lipoprotein cholesterol (LDL-C)
Measured: 8 weeks
Triglycerides (TG)
Measured: 8 weeks
Secondary outcomes (7)
Total cholesterol
Measured: 8 weeks
High-density lipoprotein cholesterol (HDL-C)
Measured: 8 weeks
non-HDL-C
Measured: 8 weeks
LDL-C/HDL-C ratio
Measured: 8 weeks
C-reactive protein
Measured: 8 weeks
Adverse events
Measured: 4 and 8 weeks
Offset effect
Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers
Measured: 2 weeks after withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed HyperlipoproteinemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- David Becker, MD, Principal investigator, Chestnut Hill Temple Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069106
- Sponsor's protocol ID
- 1001-PR-003-09092013
- Acronym
- PrOteCT
- Status last verified
- Dec 2015
- First submitted
- 20 Feb 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction in Subjects With Mixed Hyperlipoproteinemia
- ClinicalTrials.gov ID
- NCT02069106
- Acronym / sponsor ID
- PrOteCT / 1001-PR-003-09092013
- Conditions
- Mixed Hyperlipoproteinemia
- Keywords
- low density lipoprotein cholesterol, triglycerides, mixed hyperlipoproteinemia, Dehydroascorbic Acid, Eicosapentaenoic Acid, Fish oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nordic Pharma, USAIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Feb 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 21 Feb 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.
Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia.
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 |
|---|---|---|
| Pro-Omega LDL | Experimental | Dietary Supplement: Pro-Omega LDL3 capsules 1000 mg BID for 8 weeks |
| Placebo | Placebo comparator | Other: Placebo3 capsules BID for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women, ≥18 years of age.
- History (>3months) of LDL-C ≥130 mg/dl to ≤190 mg/dL
- Triglycerides (TG) > 200 to <750 mg/dL
- Able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures.
- Willing to maintain a stable diet and level of activity throughout the trial. Willing to maintain current activity level and diet throughout the trial.
Key exclusion criteria (15 listed)
- Individuals with intolerance of, or allergy to red yeast rice or omega 3 fatty acids.
- Individuals currently taking a statin (HMG-CoA Reductase inhibitor) including Lipitor, Zocor, Crestor, Pravachol, Lescol, Livalo) or other lipid metabolism altering product within four (4) weeks prior to randomization who do not wish to withdraw from therapy.
- Individual taking prescription or over the counter medications (including dietary supplements) known to alter lipid metabolism within four (4) weeks of randomization. Medications excluded within 4 weeks of randomization are: prescription omega-3 fatty acids, statins, bile acid sequestrants, cholesterol absorption inhibitors, niacin or fibrates. Dietary supplements excluded within 4 weeks prior to randomization are: L-carnitine, policosanol, guggulipid, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues, probiotics and dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplements per day and prebiotics), or any dietary supplement or vitamin complex product containing omega 3 acids or fish oil.
- Use of systemic corticosteroids, androgens (except androgens for hypogonadism to restore normal levels), phenytoin, erythromycin and other macrolides, and thyroid hormones (except stable-dose thyroid replacement therapy for four (4) weeks prior to enrollment).
- Use of the anticoagulants warfarin (Coumadin) or dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto).
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 |
|---|---|---|
| Pro-Omega LDL | Dietary supplement | Pro-Omega LDL |
| Placebo | Other | Placebo |
Primary outcome
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 8 weeks
Triglycerides (TG)
Time frame: 8 weeks
7 secondary outcomes
Total cholesterol
Time frame: 8 weeks
High-density lipoprotein cholesterol (HDL-C)
Time frame: 8 weeks
non-HDL-C
Time frame: 8 weeks
LDL-C/HDL-C ratio
Time frame: 8 weeks
C-reactive protein
Time frame: 8 weeks
Adverse events
Time frame: 4 and 8 weeks
Offset effect
Time frame: 2 weeks after withdrawal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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.
David Becker, MD principal investigator
Chestnut Hill Temple Cardiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pro-Omega LDL in people with Mixed Hyperlipoproteinemia, run by Nordic Pharma, USA.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Low-density lipoprotein cholesterol (LDL-C) (time frame: 8 weeks). 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 14 Dec 2015.