HypercholesterolemiaPhase 3NCT01071525
The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker
A Phase 3 study testing Niacin\Laropiprant in people with Hypercholesterolemia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Niacin\Laropiprant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Oct 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypercholesterolemia,
- age above eighteen
Who cannot join
- Treatment with fibrates,
- Pregnant/Breast feeding women
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Health Care Campus
Haifa, 31096
Shadi, +972-523591876, s_hamoud@rambam.health.gov.il
Tony Hayek, Prof, +972-523782009, t_hayek@rambam.health.gov.il
About this study
- Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients.
- A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible.
- Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.
- Conditions
- Hypercholesterolemia
- Being tested
- Niacin\Laropiprant
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin\LaropiprantDrug
Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant
| Study group | Role | What they receive |
|---|---|---|
| Niacin | Active comparator | Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant. Receives: Drug: Niacin\Laropiprant |
| Control | No intervention | Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests. Receives: Drug: Niacin\Laropiprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on oxidative stress
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Liz Phima, Study director, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071525
- Sponsor's protocol ID
- Niacin-OS
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 1 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker
- ClinicalTrials.gov ID
- NCT01071525
- Acronym / sponsor ID
- Niacin-OS
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 19 Feb 2010 (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.
- Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients.
- A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible.
- Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niacin | Active comparator | Drug: Niacin\LaropiprantHypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant. |
| Control | No intervention | Drug: Niacin\LaropiprantMaching subjects will receive no medication, Blood tests will be drawn for laboratory tests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypercholesterolemia,
- age above eighteen
Key exclusion criteria (2 listed)
- Treatment with fibrates,
- Pregnant/Breast feeding women
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 |
|---|---|---|
| Niacin\LaropiprantHypercholesterolemic patients with low HDL will receive Niacin\Laropiprant | Drug | Control, Niacin |
Primary outcome
Effect on oxidative stress
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2010.
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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.
Liz Phima study director
Study Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niacin\Laropiprant in people with Hypercholesterolemia, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shadi Hamoud, Dr (+972-523591876, s_hamoud@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on oxidative stress (time frame: three months). 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 1 Mar 2010.