Hyper-TriglyceridemiaPhase 4NCT00598910
Effect of Omacor on Triglycerides in HIV Infected Subjects
A Phase 4 study testing Omacor in people with Hyper-Triglyceridemia, run by Solvay Pharmaceuticals at 5 sites in 2 countries.
Trial summary
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyper-Triglyceridemia
- What is being tested?
- Omacor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2007to Mar 2009
- 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
- Triglycerides between 200 and 800
- diagnosed HIV infection
- following HAART therapy
Who cannot join
- other malignant disease
- not compliant
- allergy against fish oil
- soy or olive oil
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment
- Conditions
- Hyper-Triglyceridemia
- Being tested
- Omacor, Placebo
- Keywords
- HIV infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmacorDrug
n-3 PUFA
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Omacor |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
Measured: 12 weeks treatment
Secondary outcomes (3)
Absolute change in serum triglycerides
Measured: 12 weeks
Absolute and percent change in cholesterol and cholesterol subfractions
Measured: 12 weeks
Absolute and percent change in apolipoprotein A and B
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionMar 2009
Why it stopped: The study was discontinued prematurely on December 18 2008 due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyper-TriglyceridemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598910
- Sponsor's protocol ID
- S185.4.001
- Other IDs
- 2007-001921-86
- Status last verified
- Mar 2009
- First submitted
- 11 Jan 2008
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.
PubMed 22212377
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Investigate the Effect of Omacor (n-3 PUFA) on Lipid Parameters in HIV Infected Subjects Treated With HAART
- ClinicalTrials.gov ID
- NCT00598910
- Acronym / sponsor ID
- S185.4.001
- Conditions
- Hyper-Triglyceridemia
- Keywords
- HIV infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued prematurely on December 18 2008 due to slow recruitment
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Jan 2008 (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.
Omacor is likely to decrease lipid parameters in HIV infected subjects. In these subjects the lipid are decrease due to HAART treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Omacor |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Triglycerides between 200 and 800
- diagnosed HIV infection
- following HAART therapy
Key exclusion criteria (4 listed)
- other malignant disease
- not compliant
- allergy against fish oil
- soy or olive oil
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 |
|---|---|---|
| Omacorn-3 PUFA | Drug | A |
| PlaceboPlacebo | Drug | B |
Primary outcome
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo
Time frame: 12 weeks treatment
3 secondary outcomes
Absolute change in serum triglycerides
Time frame: 12 weeks
Absolute and percent change in cholesterol and cholesterol subfractions
Time frame: 12 weeks
Absolute and percent change in apolipoprotein A and B
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The study was discontinued prematurely on December 18 2008 due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2009.
- Derived from this study: PubMed 22212377Peters BS, Wierzbicki AS, Moyle G, Nair D, Brockmeyer N. The effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial. Clin Ther. 2012 Jan;34(1):67-76. doi: 10.1016/j.clinthera.2011.12.001. Epub 2011 Dec 31.
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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omacor in people with Hyper-Triglyceridemia, run by Solvay Pharmaceuticals at 5 sites in 2 countries.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Germany. 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 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 stopped early (reason given: The study was discontinued prematurely on December 18 2008 due to slow recruitment). Results are not available in the source record.
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?
Percent change in serum triglycerides from baseline to treatment endpoint versus placebo (time frame: 12 weeks 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 NCT00598910, which also lists 1 linked publication.
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 30 Mar 2009.