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Home > "C" Clinical Trials Conditions > Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL  Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
For Condition: Dyslipidemia,Diabetes,Stroke,Atherosclerosis,Coronary Heart Disease
Status: Recruiting
Sponsor(s): Kos Pharmaceuticals ,
Synopsis: 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.
Details: 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. Sample Size: Approximately 300 patients will be randomized equally to the four treatment groups. Multi-center: Approximately 35 sites will participate. Primary Endpoint: Mean percent change in LDL-C from Baseline to Week 12. Secondary Endpoints: Mean percent change in high density lipoprotein cholesterol (HDL-C), TG, and non-high density lipoprotein cholesterol (non-HDL-C) from Baseline to Week 12. Tertiary Endpoints: Lipid values including mean percent change in total cholesterol (TC) and the ratios of TC to HDL-C and LDL-C to HDL-C to Week 12. Safety variables such as serum transaminases, routine chemistry parameters, hematology, urinalysis, and adverse events will be evaluated as tertiary endpoints. Adverse Events: Adverse events and flushing will be volunteered by patients and elicited by study staff. Statistical Plan: All hypothesis tests will be two-sided and use a Type I error rate of 5%. The primary endpoint of mean percent change in LDL-C from Baseline to Week 12 will be evaluated using an ANOVA to assess differences across treatment groups. The secondary and tertiary endpoints will each be compared similarly across treatment groups in separate ANOVA models. If a statistically significant treatment group difference is found in an efficacy endpoint, relevant pairs of treatment groups will be compared using a procedure to control for Type I error in multiple comparisons. Adverse events will be tabulated by term and system organ class according to the MedDRA dictionary. Chi-square or Fisher’s Exact test will be used as appropriate to compare incidences between groups. Continuous-valued safety and efficacy variables will be summarized by treatment group and week using means (of observed and percent change values), the standard error of the mean, the median, the minimum, and the maximum. Discrete-valued safety and efficacy variables will be summarized by treatment group and week using frequencies and percents.
Eligibility:
Study Type: Interventional,Treatment,Randomized,Open Label,Dose Comparison,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: All of the following criteria must be answered “Yes”: 1. Patient is 21 years of age or older and willing to participate for the duration of the study; 2. 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; 3. Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability 15%; 4. Patient has mean triglyceride level (TG) 300 mg/dL; 5. 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; 6. 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. Exclusion Criteria: All the following criteria must be answered “No”: 1. Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives; 2. Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency; 3. Patient has untreated or unsuccessfully treated psychiatric disease; 4. Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs; 5. Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications); 6. 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. 7. 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; 8. Patient is planning to undergo major surgery within the next 6 months; 9. 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.
Total Enrollment: 300
Location and Contact Information:
Research Institute of Middle America River City Cardiology*Recruiting*
Jeffersonville, Indiana, 47130
United States
RecruitingJuan Ortiz
Wilford Hall US Air Force Medical Center*Not yet recruiting*
Lackland Air Force Base, Texas, 78239-5300
United States
Not yet recruitingRichard Krasuski
Primary Care Cardiology Research, Inc.*Not yet recruiting*
Ayer, Massachusetts, 01432
United States
Not yet recruitingTerrence Hack
Clinical Research Center of California*Recruiting*
San Diego, California, 92117
United States
RecruitingJeffry Mullvain
Miami Cardiology Group*Not yet recruiting*
Miami, Florida, 33176
United States
Not yet recruitingPaul Seigel
Meridian Research*Recruiting*
St. Petersburg, Florida, 33709
United States
RecruitingMildred Farmer
Future Care Studies*Not yet recruiting*
Springfield, Massachusetts, 01107
United States
Not yet recruitingAdnan Dahdul
University of Miami*Not yet recruiting*
Miami, Florida, 33136
United States
Not yet recruitingRonald Goldberg
Hampton Roads Center for Clinical Research*Recruiting*
Norfolk, Virginia, 23532
United States
RecruitingBarry Lubin
National Clinic Research*Recruiting*
Richmond, Virginia, 23294
United States
RecruitingJames McKenny
Clinical Research Consultants, Inc.*Not yet recruiting*
Trumbull, Connecticut, 06611
United States
Not yet recruitingSelwyn Cohen
Heart Care Associates, LLC*Not yet recruiting*
Milwaukee, Wisconsin, 53233
United States
Not yet recruitingYoseph Shalev
Tatum Ridge Internal Medicine*Not yet recruiting*
Phoenix, Arizona, 85032
United States
Not yet recruitingLawrence Gassner
Renstar Medical Research*Recruiting*
Plantation, Florida, 33324
United States
RecruitingOrlando Maytin
Jacksonville Heart Center, PA*Recruiting*
Jacksonville, Florida, 32250
United States
RecruitingWilliam Wainwright
L-MARC Research Center*Recruiting*
Louisville, Kentucky, 40213
United States
RecruitingHarold Bays
Omega Medical Research*Not yet recruiting*
Warwick, Rhode Island, 02886
United States
Not yet recruitingDavid Fried
Baylor College of Medicine / The Medicine / The Methodist Hospital*Not yet recruiting*
Houston, Texas, 77030
United States
Not yet recruitingPeter Jones
Fox Valley Cardiovascular Consultants*Not yet recruiting*
Aurora, Illinois, 60506
United States
Not yet recruitingSantosh Gill
Riverside Methodist Hospital*Not yet recruiting*
Columbus, Ohio, 43214
United States
Not yet recruitingJames Falko
The Lindner Clinical Trial Center*Not yet recruiting*
Cincinnati, Ohio, 45219
United States
Not yet recruitingDean Kereiakes
Iowa Heart Center, PC*Not yet recruiting*
Des Moines, Iowa, 50314
United States
Not yet recruitingWilliam Wickemeyer
Research Across America*Recruiting*
Reading, Pennsylvania, 19606
United States
RecruitingMichael Warren
Tyler Cardiovascular Consultants*Recruiting*
Tyler, Texas, 75701
United States
RecruitingC. Sanford
The Lindner Clinical Trial Center*Not yet recruiting*
Long Beach, California, 90822
United States
Not yet recruitingMoti Kashyap
Westside Family Medical Center, PC*Recruiting*
Kalamazoo, Michigan, 49009
United States
RecruitingGary Ruoff
Saint Luke's Lipid and Diabetes Research Center*Not yet recruiting*
Kansas City, Missouri, 64111
United States
Not yet recruitingAlan Forker
Northwest Lipid Research Clinic*Not yet recruiting*
Seattle, Washington, 75069
United States
Not yet recruitingRobert Knopp
Indiana University School of Medicine*Not yet recruiting*
Indianapolis, Indiana, 46202
United States
Not yet recruitingMark Deeg
COR Clinical Research*Recruiting*
Oklahoma City, Oklahoma, 73103
United States
RecruitingClinton Corder
Western Clinical Research, Inc.*Not yet recruiting*
Torrance, California, 90505
United States
Not yet recruitingOwen Robinson
Hudson Valley Clinical Research Center*Recruiting*
Kingston, New York, 12401
United States
RecruitingAmin Elashker
Carolina Pharmaceutical Research*Recruiting*
Statesville, North Carolina, 28625
United States
RecruitingJoseph Moran
Cardiac Center of Texas*Not yet recruiting*
McKinney, Texas, 75069
United States
Not yet recruitingMuhammad Khan
Additional Information:
Study ID Numbers: 001-09-03-CR; COMPELL
Study Start Date: April 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079638
Other DiabetesStudies:
1. Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
2. Obese Patients with Untreated Dyslipidemias
3. Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
4. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
5. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
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Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
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