Mixed DyslipidemiaNCT00487591
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
An observational study of Mixed Dyslipidemia, run by Provident Clinical Research.
Trial summary
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- Omacor (omega-3-acid ethyl esters)plus simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Aug 2007
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages 18-79 inclusive
- Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
- Fasting, untreated triglyceride (TG) level in the high to very high range
- Provide written informed consent and authorization for protected health information
Who cannot join
- Pregnancy
- Use of lipid-altering drugs which cannot be stopped
- History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
- Body mass index above 40 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids or to statin drugs
- Poorly-controlled conditions including diabetes, hypertension, or thyroid disease
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- Certain muscle, liver, kidney, lung or gastrointestinal conditions
- Certain medications
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
About this study
Official title: An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.
Read the detailed description
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.
- Conditions
- Mixed Dyslipidemia
- Being tested
- Omacor (omega-3-acid ethyl esters)plus simvastatin, simvastatin plus placebo
- Keywords
- cholesterol, dyslipidemia, omega 3
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omacor (omega-3-acid ethyl esters)plus simvastatinDrug
Also called Lovaza
Omacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg)
simvastatin plus placeboDrug
simvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Simva+Omacor | Not described Receives: Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin | |
| Simva + Placebo | Not described Receives: Drug: simvastatin plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in non-high-density lipoprotein cholesterol (non-HDL-C)
Measured: Baseline to end of treatment
Secondary outcomes (1)
Changes in other lipid and biomarker levels
Measured: Baseline through end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mixed DyslipidemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provident Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Pharmaceuticals
- Investigators
- Kevin C Maki, PhD, Study director, Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487591
- Sponsor's protocol ID
- PRV-06009
- Status last verified
- Apr 2008
- First submitted
- 14 Jun 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Maki KC; McKenney JM; Lubin BC; Reeves MS. Lipid effects of prescription omega-3-acid ethyl esters plus simvastatin in subjects with hypertriglyceridemia. FASEB J 2008;22:147.8
Maki KC, McKenney JM, Reeves MS, Lubin BC, Dicklin MR. Effects of adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia. Am J Cardiol. 2008 Aug 15;102(4):429-33. doi: 10.1016/j.amjcard.2008.03.078. Epub 2008 May 22.
PubMed 18678300Maki KC; McKenney JM; Reeves MS; Lubin BC; Dicklin MR. Effects of prescription omega-3-acid ethyl esters plus simvastatin on lipids and lipoprotein particles in mixed dyslipidemia. J Clin Lipidol 2008 May/June; In press
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT00487591
- Acronym / sponsor ID
- PRV-06009
- Conditions
- Mixed Dyslipidemia
- Keywords
- cholesterol, dyslipidemia, omega 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Provident Clinical ResearchUniversity, hospital or other
- Collaborators
- Reliant Pharmaceuticals
- Study start
- Nov 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 18 Jun 2007 (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.
The primary objective of this study is to compare the effect of simvastatin plus Omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.
Detailed description
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 4 (Week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/Omacor first or simvastatin/placebo first. Each treatment period consists of 6 weeks. After randomization, subjects will self-administer the study drugs once a day in the evening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simva+Omacor | – | Drug: Omacor (omega-3-acid ethyl esters)plus simvastatin |
| Simva + Placebo | – | Drug: simvastatin plus placebo |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, ages 18-79 inclusive
- Fasting, untreated non-high-density lipoprotein cholesterol (non-HDL-C level above ATP III goals
- Fasting, untreated triglyceride (TG) level in the high to very high range
- Provide written informed consent and authorization for protected health information
Key exclusion criteria (9 listed)
- Pregnancy
- Use of lipid-altering drugs which cannot be stopped
- History of certain cardiovascular conditions or cardiac surgery within the prior 6 months
- Body mass index above 40 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids or to statin drugs
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 |
|---|---|---|
| Omacor (omega-3-acid ethyl esters)plus simvastatinAlso: LovazaOmacor(omega-3-acid ethyl esters) - 4/g day (4 one gram capsules) simvastatin - 20 mg/day (1 tablet/20 mg) | Drug | Simva+Omacor |
| simvastatin plus placebosimvastatin 20mg/day (1 tablet 20 mg)plus 4 capsules matching placebo | Drug | Simva + Placebo |
Primary outcome
Change in non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: Baseline to end of treatment
1 secondary outcome
Changes in other lipid and biomarker levels
Time frame: Baseline through end of treatment
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 7 May 2008.
- Results publicationMaki KC; McKenney JM; Lubin BC; Reeves MS. Lipid effects of prescription omega-3-acid ethyl esters plus simvastatin in subjects with hypertriglyceridemia. FASEB J 2008;22:147.8
- Results publication: PubMed 18678300Maki KC, McKenney JM, Reeves MS, Lubin BC, Dicklin MR. Effects of adding prescription omega-3 acid ethyl esters to simvastatin (20 mg/day) on lipids and lipoprotein particles in men and women with mixed dyslipidemia. Am J Cardiol. 2008 Aug 15;102(4):429-33. doi: 10.1016/j.amjcard.2008.03.078. Epub 2008 May 22.
- Results publicationMaki KC; McKenney JM; Reeves MS; Lubin BC; Dicklin MR. Effects of prescription omega-3-acid ethyl esters plus simvastatin on lipids and lipoprotein particles in mixed dyslipidemia. J Clin Lipidol 2008 May/June; In press
Related trials for Mixed Dyslipidemia
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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.
Kevin C Maki, PhD study director
Provident Clinical Research
Questions about this trial
What is this clinical trial studying?
An observational study of Mixed Dyslipidemia, run by Provident Clinical Research.
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 9 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 7 May 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in non-high-density lipoprotein cholesterol (non-HDL-C) (time frame: Baseline to end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487591, which also lists 3 linked publications.
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 7 May 2008.