HyperlipidemiaPhase 4NCT00203476
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
A Phase 4 study testing Niacin, Colestipol and Ezetimibe in people with Hyperlipidemia and Hypercholesterolemia, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hyperlipidemia, Hypercholesterolemia
- What is being tested?
- Niacin, Colestipol and Ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans eligible for treatment at the Tuscaloosa VA Medical Center
- 50 years of age
- Male or female
- Any race or ethnic group
- Signed informed consent
- Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase inhibitor (statin) for > 6 weeks
- Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol
Who cannot join
- Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
- Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
- Consumes more than 8oz. grapefruit juice daily
- Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
- Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, 35404
About this study
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
Read the detailed description
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.
- Conditions
- Hyperlipidemia, Hypercholesterolemia
- Being tested
- Niacin, Colestipol, Ezetimibe
- Keywords
- ezetimibe, niacin, colestipol, hyperlipidemia, adjunct therapy, zetia
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
ColestipolDrug
EzetimibeDrug
Also called Zetia
| Study group | Role | What they receive |
|---|---|---|
| Statin with Niacin | Active comparator | Niacin dose range of 500-1500mg (average 888mg) Receives: Drug: Niacin |
| Statin with Colestipol | Active comparator | Colestipol dose range 5-15gm (average 9.5gm) Receives: Drug: Colestipol |
| Statin with Ezitimibe | Active comparator | Ezitimibe 10mg (average 10mg) Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Goal Attainment
Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
Measured: 12 weeks
Secondary outcomes (3)
LFT Elevation
Measured: 12 weeks
Incidents of Rhabdomyolysis
Measured: 12 weeks
Change in HDL From Baseline to 12 Weeks.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Responsible party
- Principal investigator, Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Raela B Williford, PharmD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203476
- Sponsor's protocol ID
- TREAC Cholesterol Study
- Other IDs
- TREAC Cholesterol Study
- Status last verified
- Aug 2014
- First submitted
- 12 Sep 2005
- Last updated
- 12 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. doi: 10.1007/s11883-005-0072-7.
PubMed 15683599
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
- ClinicalTrials.gov ID
- NCT00203476
- Acronym / sponsor ID
- TREAC Cholesterol Study
- Conditions
- Hyperlipidemia, Hypercholesterolemia
- Keywords
- ezetimibe, niacin, colestipol, hyperlipidemia, adjunct therapy, zetia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.
Detailed description
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Statin with Niacin | Active comparator | Drug: NiacinNiacin dose range of 500-1500mg (average 888mg) |
| Statin with Colestipol | Active comparator | Drug: ColestipolColestipol dose range 5-15gm (average 9.5gm) |
| Statin with Ezitimibe | Active comparator | Drug: EzetimibeEzitimibe 10mg (average 10mg) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veterans eligible for treatment at the Tuscaloosa VA Medical Center
- 50 years of age
- Male or female
- Any race or ethnic group
- Signed informed consent
Key exclusion criteria (5 listed)
- Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
- Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
- Consumes more than 8oz. grapefruit juice daily
- Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
- Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol
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 | Drug | Statin with Niacin |
| Colestipol | Drug | Statin with Colestipol |
| EzetimibeAlso: Zetia | Drug | Statin with Ezitimibe |
Primary outcome
LDL Goal Attainment
Time frame: 12 weeks
Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
3 secondary outcomes
LFT Elevation
Time frame: 12 weeks
Incidents of Rhabdomyolysis
Time frame: 12 weeks
Change in HDL From Baseline to 12 Weeks.
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15683599Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. doi: 10.1007/s11883-005-0072-7.
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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.
Raela B Williford, PharmD principal investigator
Tuscaloosa Veterans Affairs Medical Center
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, Colestipol and Ezetimibe in people with Hyperlipidemia and Hypercholesterolemia, run by Tuscaloosa Research & Education Advancement Corporation 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 7 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 12 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LDL Goal Attainment (time frame: 12 weeks). 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 NCT00203476, 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 12 Aug 2014.