DyslipidemiaPhase 4NCT00079638
Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
A Phase 4 study testing Niacin, Atorvastatin and Simvastatin in people with Dyslipidemia and Coronary Heart Disease, run by Kos Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dyslipidemia, Coronary Heart Disease, Atherosclerosis
- What is being tested?
- Niacin, Atorvastatin and Simvastatin
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to May 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following criteria must be answered "Yes":
- Patient is 21 years of age or older and willing to participate for the duration of the study;
- Patient has read, signed, and agreed to the items listed in the informed consent form and HIPAA authorization form prior to the initiation of any study procedures and/or discontinuing any medications;
- Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability ≤ 15%;
- Patient has mean triglyceride level (TG) ≤ 300 mg/dL;
- Patient is willing to withdraw from any current anti-dyslipidemic medications or other prohibited medication for approximately 6 weeks prior to randomization (4 weeks prior to qualification visits) and for the duration of the study;
- If the patient is female, the patient must not be pregnant or breast-feeding and not planning to become pregnant or to breast-feed for the duration of the study. Women of childbearing potential must commit to using a medically acceptable method of birth control such as oral contraception, intrauterine device (IUD), or a double-barrier method of contraception. Women using oral contraception must have done so for at least 3 months prior to randomization, and continue to do so for the duration of the study. To be considered not of childbearing potential, women must be post-menopausal for at least 2 years or surgically sterile.
Who cannot join
- All the following criteria must be answered "No":
- Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;
- Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;
- Patient has untreated or unsuccessfully treated psychiatric disease;
- Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;
- Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
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- Patient has a history of any of the following:
- active gallbladder disease within the preceding 12 months (cholecystectomy is allowed);
- pancreatitis;
- liver disease (e.g., hepatitis B and/or C);
- persistent uncontrolled or untreated severe hypertension;
- Type I or Type II diabetes;
- persistent uncontrolled or untreated hypothyroidism;
- arterial bleeding;
- unstable angina;
- myocardial infarction, coronary artery bypass graft surgery, or angioplasty within the preceding 6 months;
- stroke, transient ischemic attack (TIA), or deep vein thrombosis (DVT) within the preceding 6 months;
- congestive heart failure NYHA class III or IV;
- active cancer within the last 5 years or a diagnosis of cancer within the last 5 years (excluding basal cell carcinoma);
- fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain or weakness, and/or discontinuation of a statin because of myalgia; and/or
- life expectancy < 2 years.
- Patient has any of the following abnormalities at any of the Screening or Qualification Visits:
- CPK elevation > 3xULN;
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.3xULN;
- serum creatinine ≥ 1.5 mg/dL;
- creatinine clearance < 30 mL/min, as calculated using the Cockroft and Gault formula by the central laboratory;
- active gout symptoms and/or uric acid level > 1.3xULN;
- and/or active peptic ulcer disease;
- Patient is planning to undergo major surgery within the next 6 months;
- Patient has any health condition or laboratory abnormality that, in the opinion of the Principal Investigator, may be adversely affected by the procedures or medications in this study.
About this study
Official title: Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies
The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
Read the detailed description
Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)
Study Treatment: Four open-label parallel treatment groups for 12 weeks of observation
- Niaspan and atorvastatin combination treatment titrated to 2000 mg and 40 mg, respectively;
- combination treatment of simvastatin titrated to 40 mg and ezetimibe maintained at 10 mg;
- rosuvastatin monotherapy treatment titrated to 40 mg; and
- Niaspan and rosuvastatin combination treatment titrated to 1000 mg and 20 mg, respectively.
Objective: To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia.
Population:
- Male or female patients 21 years of age or older
- Patients who are eligible for treatment based upon National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) recommendations at the end of the Qualification period;
- All patients must have mean triglycerides (TG) ≤ 300 mg/dL.
Design: A Phase IV, 12-week, randomized, multi-center, open-label, four-arm, parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy.
- Conditions
- Dyslipidemia, Coronary Heart Disease, Atherosclerosis, Stroke, Diabetes
- Being tested
- Niacin, Atorvastatin, Simvastatin, Ezetimibe, Rosuvastatin
- Keywords
- Niaspan, Niacin, Statin, Cholesterol, Triglycerides, Lipid-Modifying Therapies, Dyslipidemia, Coronary Heart Disease, Atherosclerosis, Stroke, VA-HIT, Niacin Statin Combination Threrapy, High Density Lipoprotein, Low Density Lipoprotein, Hypertension, Diabetes, Adult Treatment Panel III
- Medical subject headings
- Dyslipidemias, Coronary Disease, Atherosclerosis, Stroke, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiacinDrug
AtorvastatinDrug
SimvastatinDrug
EzetimibeDrug
RosuvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in LDL-C from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startApr 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Kos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- COMPELL TEAM, Principal investigator, Contact COMPELL Team Member (800) 722-4567
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079638
- Sponsor's protocol ID
- 001-09-03-CR
- Other IDs
- COMPELL
- Status last verified
- Oct 2006
- First submitted
- 10 Mar 2004
- Last updated
- 1 Nov 2006
- Results posted
- No
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
- Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies
- ClinicalTrials.gov ID
- NCT00079638
- Acronym / sponsor ID
- 001-09-03-CR
- Conditions
- Dyslipidemia, Coronary Heart Disease, Atherosclerosis, Stroke, Diabetes
- Keywords
- Niaspan, Niacin, Statin, Cholesterol, Triglycerides, Lipid-Modifying Therapies, Dyslipidemia, Coronary Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Kos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- May 2005
- First posted
- 12 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 study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
Detailed description
Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)
Study Treatment: Four open-label parallel treatment groups for 12 weeks of observation
- Niaspan and atorvastatin combination treatment titrated to 2000 mg and 40 mg, respectively;
- combination treatment of simvastatin titrated to 40 mg and ezetimibe maintained at 10 mg;
- rosuvastatin monotherapy treatment titrated to 40 mg; and
- Niaspan and rosuvastatin combination treatment titrated to 1000 mg and 20 mg, respectively.
Objective: To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia.
Population:
- Male or female patients 21 years of age or older
- Patients who are eligible for treatment based upon National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) recommendations at the end of the Qualification period;
- All patients must have mean triglycerides (TG) ≤ 300 mg/dL.
Design: A Phase IV, 12-week, randomized, multi-center, open-label, four-arm, parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy.
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 (7 listed)
- Patient is 21 years of age or older and willing to participate for the duration of the study;
- Patient has read, signed, and agreed to the items listed in the informed consent form and HIPAA authorization form prior to the initiation of any study procedures and/or discontinuing any medications;
- Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability ≤ 15%;
- Patient has mean triglyceride level (TG) ≤ 300 mg/dL;
- Patient is willing to withdraw from any current anti-dyslipidemic medications or other prohibited medication for approximately 6 weeks prior to randomization (4 weeks prior to qualification visits) and for the duration of the study;
Key exclusion criteria (30 listed)
- Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;
- Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;
- Patient has untreated or unsuccessfully treated psychiatric disease;
- Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;
- Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
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 | – |
| Atorvastatin | Drug | – |
| Simvastatin | Drug | – |
| Ezetimibe | Drug | – |
| Rosuvastatin | Drug | – |
Primary outcome
Mean percent change in LDL-C from Baseline to Week 12
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.
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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.
COMPELL TEAM principal investigator
Contact COMPELL Team Member (800) 722-4567
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Niacin, Atorvastatin and Simvastatin in people with Dyslipidemia and Coronary Heart Disease, 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 7 inclusion and 30 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 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?
Mean percent change in LDL-C from Baseline to Week 12. 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 Nov 2006; AzTrials last refreshed its copy on 6 Nov 2026.