HyperlipidemiaPhase 4NCT00345657
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
A Phase 4 study testing Niacin Extended Release/Lovastatin in people with Hyperlipidemia and Mixed Hyperlipidemia, run by In His Image at 1 site in United States.
Trial summary
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia
- What is being tested?
- Niacin Extended Release/Lovastatin
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2004
- 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
- >18 years old with CAD or risk factors for CAD
- under standard care at Family Medical Care of Tulsa
- not at LDL goal per ATP III guidelines
Who cannot join
- pregnancy/lactating
- liver disease
- allergies to statin or niacin
- active peptic ulcer disease
- previous treatment with combination therapy for dyslipidemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Read the detailed description
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
- Conditions
- Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia
- Being tested
- Niacin Extended Release/Lovastatin
- Keywords
- Hyperlipidemia, Dyslipidemia, Niacin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin
- Medical subject headings
- Hyperlipidemias, Hyperlipoproteinemia Type II, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin Extended Release/LovastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid parameter change at 3 and 6 months
Percent of patients achieving ATP III LDL goals at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJul 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- In His Image
- Sponsor type
- University, hospital or other
- Collaborators
- Kos Pharmaceuticals
- Investigators
- Jason A Logan, MD, Principal investigator, In His Image Family Medicine ResidencyEdward Rylander, MD, Study chair, In His Image Family Medicine Residency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345657
- Sponsor's protocol ID
- IHI-A001
- Status last verified
- Jun 2006
- First submitted
- 27 Jun 2006
- Last updated
- 28 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
- ClinicalTrials.gov ID
- NCT00345657
- Acronym / sponsor ID
- IHI-A001
- Conditions
- Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia
- Keywords
- Hyperlipidemia, Dyslipidemia, Niacin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- In His ImageUniversity, hospital or other
- Collaborators
- Kos Pharmaceuticals
- Study start
- Jul 2003
- Study completion
- May 2004
- First posted
- 28 Jun 2006 (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 study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Detailed description
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old with CAD or risk factors for CAD
- under standard care at Family Medical Care of Tulsa
- not at LDL goal per ATP III guidelines
Key exclusion criteria (5 listed)
- pregnancy/lactating
- liver disease
- allergies to statin or niacin
- active peptic ulcer disease
- previous treatment with combination therapy for dyslipidemia
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/Lovastatin | Drug | – |
Primary outcome
Lipid parameter change at 3 and 6 months
Percent of patients achieving ATP III LDL goals at 3 and 6 months
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 28 Jun 2006.
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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.
Jason A Logan, MD principal investigator
In His Image Family Medicine Residency
Edward Rylander, MD study chair
In His Image Family Medicine Residency
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 Niacin Extended Release/Lovastatin in people with Hyperlipidemia and Mixed Hyperlipidemia, run by In His Image 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 3 inclusion and 5 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 28 Jun 2006. 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.
What does the primary outcome measure?
Lipid parameter change at 3 and 6 months. The study lists 2 primary outcomes in all. 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 28 Jun 2006.