HypercholesterolemiaPhase 3NCT00080275
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
A Phase 3 study testing Niacin Extended-Release and simvastatin Tablets in people with Hypercholesterolemia, run by Kos Pharmaceuticals.
Trial summary
The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia). At least 600 subjects with a similar medical condition will take part in this study. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Niacin Extended-Release and simvastatin Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to not given
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
- If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
- LDL-C levels and/or non HDL-C levels above normal.
- Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
Who cannot join
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
- HbA1c ≥ 9% in diabetic patients
About this study
Official title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).
At least 600 subjects with a similar medical condition will take part in this study.
Read the detailed description
Objectives:
To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.
- Conditions
- Hypercholesterolemia
- Being tested
- Niacin Extended-Release and simvastatin Tablets
- Keywords
- Niacin, Statin, Zocor, Simvastatin, Coronary Heart Disease, Dyslipidemia, Atherosclerosis, Hypercholesterolemia, Stroke, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Lipoprotein, Lipid, Niacin ER/simvastatin, Total Cholesterol, Triglycerides
- Medical subject headings
- Hypercholesterolemia, Coronary Disease, Dyslipidemias, Atherosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin Extended-Release and simvastatin TabletsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2004 (estimated)
- Study startMar 2004
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Kos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080275
- Sponsor's protocol ID
- 019-02-03-CR
- Other IDs
- OCEANS
- Status last verified
- Oct 2006
- First submitted
- 25 Mar 2004
- Last updated
- 1 Nov 2006
- Results posted
- No
Publications
Karas RH, Kashyap ML, Knopp RH, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;8(2):69-81. doi: 10.2165/00129784-200808020-00001.
PubMed 18422390
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
- ClinicalTrials.gov ID
- NCT00080275
- Acronym / sponsor ID
- 019-02-03-CR
- Conditions
- Hypercholesterolemia
- Keywords
- Niacin, Statin, Zocor, Simvastatin, Coronary Heart Disease, Dyslipidemia, Atherosclerosis, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Kos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- First posted
- 29 Mar 2004 (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 purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).
At least 600 subjects with a similar medical condition will take part in this study.
Detailed description
Objectives:
To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has primary Type II hyperlipidemia or mixed dyslipidemia.
- If the patient is currently taking a lipid modifying medication other than Zocor \& he/she is willing to discontinue this medication
- LDL-C levels and/or non HDL-C levels above normal.
- Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
Key exclusion criteria (2 listed)
- Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives.
- HbA1c ≥ 9% in diabetic patients
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 Extended-Release and simvastatin Tablets | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Nov 2006.
- Derived from this study: PubMed 18422390Karas RH, Kashyap ML, Knopp RH, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;8(2):69-81. doi: 10.2165/00129784-200808020-00001.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Niacin Extended-Release and simvastatin Tablets in people with Hypercholesterolemia, run by Kos Pharmaceuticals.
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 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: finished, as of the sponsor's last update on 1 Nov 2006. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080275, 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 1 Nov 2006.