Coronary Artery DiseasePhase 4NCT00590629
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
A Phase 4 study testing Niaspan in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Niaspan
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Nov 2005
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
Who cannot join
- History of MI, PTCA or surgery within previous 3 months
- Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
- Active or known gall bladder disease
- Pregnant or nursing women
- Significant comorbidity that precludes participation
- Significant liver disease, active alcoholism, or LFT >1.5x's ULN at screening
- Diabetes or glucose > 126 mg/dl at screening
- PI perceived inability to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women.
Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.
- Conditions
- Coronary Artery Disease
- Being tested
- Niaspan
- Keywords
- Women with and without CAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiaspanDrug
1500 mg Niaspan for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJun 2002
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- General Clinical Research Center (GCRC), Kos Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590629
- Sponsor's protocol ID
- HDL3954
- Other IDs
- GCRC: Grant #MO1-RR00425
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
- ClinicalTrials.gov ID
- NCT00590629
- Acronym / sponsor ID
- HDL3954
- Conditions
- Coronary Artery Disease
- Keywords
- Women with and without CAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- General Clinical Research Center (GCRC), Kos Pharmaceuticals
- Study start
- Jun 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 10 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.
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women.
Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
Key exclusion criteria (8 listed)
- History of MI, PTCA or surgery within previous 3 months
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 |
|---|---|---|
| Niaspan1500 mg Niaspan for 16 weeks | 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 14 Sep 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Niaspan in people with Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
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 1 inclusion and 8 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 14 Sep 2011. 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 United States. 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 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 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?
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 Sep 2011.