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Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST Clinical research trials and Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST. Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST clinical trial. Human subjects often get the best healthcare possible for their Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST  Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
For Condition: Dyslipidemia
Status: Recruiting
Sponsor(s): Kos Pharmaceuticals ,
Synopsis: Nature and Purpose of this Study: The purpose of this study is to compare the effectiveness and safety of Niacin ER and Simvastatin (NS), in patients with elevated fat levels in their blood (dyslipidemia). At least 575 patients, with a similar medical condition to yours will also take part in this study, at approximately 50 sites within the United States. Niacin and simvastatin are medications that have been individually approved by the United States Food and Drug Administration (FDA) to treat high cholesterol. Kos has developed an investigational formula combining both niacin and simvastatin, named in this study as NS, for the treatment of cholesterol and lipid disorders (high fat content in your blood). The NS tablet (study medication) is created with different dosages of combined niacin extended-release (ER) and simvastatin immediate release (IR). The use of NS to treat lipid disorders is considered investigational. An investigational use is one that is not approved by the FDA. Duration of the Study: The entire study will last between 26 and 44 weeks, including Screening and Qualification Visits. The first phase is called the Screening Phase. This helps to determine whether you are a qualified candidate for this study (lasting 6 to 8 weeks). The next phase is called the Run-In and Lipid Qualification Phase (between 6 and 18 weeks). During this phase, you will be given Zocor 40 mg, to help achieve lipid goals. If your lipid goals are not met, you will be eligible for the Treatment Phase to determine if NS can lower your lipid levels. The Treatment Phase will be started with a randomization procedure (explained further in the next section). During this phase, you will receive study medication for 20 weeks. Details of Tests and Procedures - Screening Phase: During the screening process, you must be NCEP TLC 1 Diet compliant for at least 6 weeks or undergo a 6 week diet lead-in. This means that you will be required to follow a special diet made up of nutritional guidelines (diet instructions will be given, if needed). You will be asked to keep a diet log, in which you record all the food you have eaten during each day. This log will be collected at each visit to be sure that you have followed the diet throughout the study.
Details: Design: This is a multi-center, parallel group study, in which treatment in the open-label Run-In Phase stratifies patients for the double-blind Treatment Phase. Patients meeting the inclusion and exclusion criteria for randomization, who are NCEP TLC diet compliant and receiving monotherapy with Zocor 20 mg or 40 mg for ≥ 6 weeks at Screening or after Run-In are evaluated for Lipid Qualification. Patients meeting the Lipid Qualification criteria after “Zocor 20 mg Run-In” are then qualified to be randomized to one of the four Simvastatin Low-Dose (SLD) Treatment Groups. Patients meeting the Lipid Qualification criteria after “Zocor 40 mg Run-In” are then qualified to be randomized to one of the three Simvastatin High-Dose (SHD) Treatment Groups. The duration of the Screening and Run-In Phases is based on diet compliance, anti-dyslipidemic drug therapy at Screening, and length of the Zocor Run-In (e.g., length of time may double if patient needs to complete both Zocor 20 mg and Zocor 40 mg Run-In Phases in order to qualify). The Treatment Phase is double-blinded, and follows a parallel-group, dose-escalating study design that lasts 20 weeks. Objective: To evaluate the safety and efficacy of second-line therapy with Niacin ER and Simvastatin IR (NS) relative to monotherapy with Zocor in patients who do not satisfy NCEP ATP III lipid goals. Population: Men and women, 21 years of age or older, with Type II hyperlipidemia (i.e., patient does not have hyperlipidemia caused by an uncontrolled, underlying disease state such as hypothyroidism) who meet the specified diet, lipid, and safety laboratory criteria at Screening may continue with the Run-In Phase. The major criteria for randomization include: · Mean triglycerides < 500 mg/dL; · ALT and AST ≤ 1.3 times upper limit of normal (ULN); · CPK ≤ 3 times ULN; · LDL-C and/or non-HDL-C levels that warrant treatment based upon the NCEP ATP III Expert Panel guidelines1; and · Compliance with the NCEP TLC diet for at least 6 weeks prior to Qualification 1 will be confirmed by a 24-hour diet recall. Screening and Run-In Phases: Four distinct patient groups will be screened for this study: A. No Medication Group This group consists of patients who are not taking any lipid modifying medication at Screening who meet all screening entry criteria but who do not satisfy the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Low-Density Lipoprotein Cholesterol (LDL-C) goals (Refer to Table 1, Section 4.1). To be eligible for continuation, patients must be reasonably compliant to the TLC diet (Refer to Section 4.1 for the definition of “reasonable dietary compliance”). Patients meeting the screening criteria will then be placed into the Zocor 20 mg Run-In Phase for 6 weeks where they must also continue their level of TLC diet compliance. These patients will then be evaluated for Lipid Qualification (while continuing Zocor 20 mg). B. Zocor 20 mg Group: This group consists of patients receiving Zocor 20 mg daily at Screening. These patients must meet one or more of the lipid entry criteria based on NCEP CHD risk or risk factors to continue in the study (Refer to Table 2, Section 4.1), at Screening. During Run-In, patients will initially receive Zocor 20 mg for 6 weeks while maintaining reasonable compliance to the NCEP TLC diet. Patients previously taking Zocor 20 mg for > 6 weeks may be exempt from Run-In and move directly to Lipid Qualification if they were dietary compliant for ≥ 6 weeks as well. These patients will then be evaluated for Lipid Qualification (while continuing Zocor 20 mg). Based on the results of the Lipid Qualification Phase, patients will either be randomized, withdrawn from further participation, or be placed into the Zocor 40 mg Run-In Phase for an additional 6 weeks. C. Zocor 40 mg Group: This group consists of patients taking Zocor 40 mg at Screening. Patients receiving Zocor 40 mg daily at Screening must meet one or more of the lipid entry criteria (Refer to Table 2, Section 4.1). Prior to the Lipid Qualification Phase, patients must have taken Zocor 40 mg for ≥ 6 weeks and must maintain reasonable compliance to the NCEP TLC diet for ≥ 6 weeks. If a patient has taken this medication regimen for ≥ 6 weeks, has been reasonably NCEP TLC diet compliant for at least 6 weeks prior to Screening, and has satisfied all other screening criteria, the Run-In Phase will be skipped and the patient will proceed directly to Lipid Qualification. D. Other Medication Group: This group consists of patients who are taking Zocor 5 mg or 10 mg or any lipid modifying medications other than Zocor 20 mg or 40 mg at Screening. Patients receiving Zocor > 40 mg are ineligible for the study. These patients will discontinue taking their current lipid modifying medications at Screening and enter the Zocor 20 mg Run-In Phase for 6 weeks where they must also continue their level of TLC diet compliance. These patients will then be evaluated for Lipid Qualification (while continuing Zocor 20 mg). Randomization: Randomization occurs after Lipid Qualification has been demonstrated and may be considered as the initiation of the Treatment Phase. Patients are randomized as follows: Simvastatin Low-Dose Treatment Group (SLD): Patients taking Zocor 20 mg at end of the Lipid Qualification Phase will be randomized into one of the following dose-escalating NS and simvastatin treatment arms: · Niacin ER/Simvastatin IR 1000/20 · Niacin ER/Simvastatin IR 2000/20 · Simvastatin 20 mg · Simvastatin 40 mg Simvastatin High-Dose Treatment Group (SHD): Patients taking Zocor 40 mg at the end of the Lipid Qualification Phase will be randomized into one of the following dose-escalating NS and simvastatin treatment arms: · Niacin ER/Simvastatin IR 1000/40 · Niacin ER/Simvastatin IR 2000/40 · Simvastatin 80 mg Treatment Phase (double-blind): This phase refers to the time period from Randomization to Week 20 (or Early Termination). Study medication will be taken once daily with a low-fat snack at bedtime. Patients will be advised that one 325 mg non-enteric coated aspirin may be taken ½ hour prior to study medication to help prevent possible flushing effects commonly associated with niacin products. Patients already taking 325 mg non-enteric coated aspirin for prophylaxis (e.g., for heart disease) will be advised to take the aspirin ½ hour prior to taking study medication. The Site will notify the Sponsor regarding patients who are taking other aspirin formulations.
Eligibility:
Study Type: Interventional,Treatment,Randomized,Double-Blind,Active Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1) Women must not be pregnant or breast-feeding & should not be planning to become pregnant or to breast-feed during the study. Women of childbearing potential must commit to using oral contraception, IUD, or a double-barrier method of contraception. Women using oral contraception must have done so for 3 months prior to the Run-In Phases, & 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. 2) Willing to participate for the duration of the study & agree to & signed HIPAA & written informed consent. 3) Has primary Type II hyperlipidemia 4) If taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications for the duration of the study. 5) Is described as one of the following: - Not receiving any anti-dyslipidemic medication & meets LDL-C entry criterion - Receiving Zocor 20mg & meets the LDL-C &/or the non-HDL-C entry criteria - Receiving Zocor 40mg & meets the LDL-C &/or the non-HDL-C entry criteria - Receiving Zocor 5mg or 10mg or any lipid modifying medications other than Zocor 20mg or 40mg at Screening (patients receiving Zocor >40mg are ineligible for the study) & meets the LDL-C &/or the non-HDL-C entry criteria 6) Is willing to withdraw from prohibited medications for the duration of the study. 7) Is compliant with the NCEP TLC diet for a minimum of 6 weeks prior to Qualification Visits 8) Patients qualified for study enrollment must meet all of the following lab criteria: At Screening &/or Qualification: - Mean triglyceride levels <500mg/dL - CPK 3 X ULN - ALT & AST 1.3 X ULN At Qualification: - LDL-C Variability 15%. The LDL-C values of two consecutive blood samples drawn at Qual 1 & Qual 2 (Qual 3, if necessary), taken 7 ± 3 days apart, must be within 15% of each other. - Based on the average LDL-C & non-HDL-C values at Qualification Visits 1 & 2 (or 2 & 3, if required), LDL-C &/or non-HDL-C does not satisfy NCEP ATP III treatment goals. Exclusion Criteria: 1) Has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives. 2) Has >14 alcoholic drinks per week or a history of substance abuse or dependency within 12 months. 3) Has untreated or unsuccessfully treated psychiatric disease. 4) Has used an investigational study medication or participated in an investigational study within 30 days prior to the Screening Phase. 5) Has taken a prohibited medication within 6 weeks prior to the Run-In Phase. 6) Has a history of any the following assessed at Screening: - active gallbladder disease within the preceding 12 months (cholecystectomy is allowed); - pancreatitis; - liver disease - persistent treated or untreated severe hypertension; - arterial bleeding; - unstable angina; - myocardial infarction within the preceding 6 months; - coronary artery bypass graft surgery within the preceding 6 months; - angioplasty within the preceding 6 months; - stroke, TIA, or DVT within the preceding 6 months; - congestive heart failure NYHA class III or IV; - Type I diabetes, or uncontrolled Type II; - active cancer or a diagnosis of cancer within the last 5 years - fibromyalgia, myopathy, rhabdomyolysis, unexplained muscle pain &/or discontinuation of statin due to myalgia 7) Has any of the following abnormalities at any of the Screening or Qualification Visits: - AST or ALT >1.3 X ULN; - creatinine clearance < 30 mL/min, as calculated by central lab; - CPK elevation >3 X ULN; - HbA1C >8.0%; - active gout symptoms &/or uric acids level >1.3 X ULN; - active peptic ulcer disease; - active hepatitis, active liver disease; &/or - life expectancy <2 years 8) At Screening, patient is receiving Zocor > 40mg daily.
Total Enrollment: 525
Location and Contact Information:
Berman Center for Outcomes and Clinical Research *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Richard Jr.
Weill Medical College of Cornell University *Not yet recruiting*
New York City, New York, 10021
United States
Not yet recruiting Bassem El-Masri
The Center for Diabetes and Endocrine Care *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Sam Lerman
Cedar-Crosse Research Center *Recruiting*
Chicago, Illinois, 60607
United States
Recruiting Danny Sugimoto
AMULET, LLC *Recruiting*
New Orleans, Louisiana, 70124
United States
Recruiting Robert Larimer
Discovery Alliance, Inc c/o Trinity Cardiology *Recruiting*
Mesa, Arizona, 85206
United States
Recruiting James DelGiorno
George Washington University Lipid Research Clinic *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Judith Hsia
CD Hanshaw, DO Inc. *Recruiting*
Dayton, Ohio, 45458
United States
Recruiting Charles Hanshaw
L-MARC Research Center *Not yet recruiting*
Louisville, Kentucky, 40213
United States
Not yet recruiting Harold Bays
University of Miami Research Institute *Recruiting*
Miami, Florida, 33136
United States
Recruiting Ronald Goldberg
Radiant Research *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting David Perling
Maine Center for Lipids and Cardiovascular Health *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Leonard Keilson
Radiant Research *Recruiting*
Columbus, Ohio, 43212
United States
Recruiting Douglas Schumacher
Radiant Research *Recruiting*
Tucson, Arizona, 85710
United States
Recruiting Robert Hirsch
Richard Christensen, MD *Recruiting*
Boise, Idaho, 83702
United States
Recruiting Richard Christensen
Hillsboro Cardiology, PC, Clinical Research *Recruiting*
Hillsboro, Oregon, 97123
United States
Recruiting Steven Promisloff
Radiant Research - Honolulu *Recruiting*
Honolulu, Hawaii, 96814
United States
Recruiting Richard Wasnich
Cardiovascular Genetics *Recruiting*
Salt Lake City, Utah, 84108
United States
Recruiting Eliot Brinton
Radiant Research *Recruiting*
San Diego, California, 92108
United States
Recruiting Laurence Sherman
University of Florida Department of Medicine *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting Laurence Kennedy
The Greater Fort Lauderdale Heart Group Research *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Alan Niederman
New Orleans Center for Clinical Research *Recruiting*
New Orleans, Louisiana, 70119
United States
Recruiting William Smith
Clinical Research Puerto Rico, Inc. *Recruiting*
San Juan, , 00909-1711
Puerto Rico
Recruiting Sonia Valsquez
Miami Research Associates *Recruiting*
Coral Gables, Florida, 33146
United States
Recruiting Theodore Feldman
Southwest Florida Heart Group *Recruiting*
Ft. Myers, Florida, 33919
United States
Recruiting Joseph O'Bryan
University of Rochester *Recruiting*
Rochester, New York, 14618
United States
Recruiting Thomas Pearson
Radiant Research / Akron *Recruiting*
Mogadore, Ohio, 44260
United States
Recruiting Dennis McCluskey
Syracuse Preventive Cardiology *Recruiting*
Syracuse, New York, 13202
United States
Recruiting Stephen Nash
Piedmont Medical Research Associates *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Thomas Littlejohn
Radiant Research *Recruiting*
Greer, South Carolina, 29651
United States
Recruiting William Ellison
VA Medical Center *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting William Cushman
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Michael Davidson
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting William Jr.
University of South Alabama *Recruiting*
Mobile, Alabama, 36693
United States
Recruiting Robert Kreisberg
Radiant Research *Recruiting*
Birmingham, Alabama, 65209
United States
Recruiting Lisa Wright
Stanford Center for Research in Disease Prevention *Recruiting*
Palo Alto, California, 94304-1825
United States
Recruiting Stephen Fortmann
The Jefferson Heart Institute *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting David Capuzzi
Midwest Institute For Clinical Research *Recruiting*
Indianapolis, Indiana, 46260
United States
Recruiting Phillip Toth
Radiant Research, Kansas City *Recruiting*
Kansas City, Kansas, 66112
United States
Recruiting Elizabeth Gallup
Hampton Roads Center for Clinical Research, Inc *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Barry Lubin
National Clinical Research, Inc *Recruiting*
Richmond, Virginia, 23294
United States
Recruiting James McKenney
Radiant Research Inc. *Recruiting*
Anderson, South Carolina, 29621
United States
Recruiting Harry Geisberg
Pro Research Group, LLC *Recruiting*
San Antonio, Texas, 78224
United States
Recruiting Raul Gaona
Torrance Clinical Research *Recruiting*
Torrance, California, 90505
United States
Recruiting Marina Raikhel
Northwestern University Medical *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Robert Rosenson
Saint Louis University *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Kent Wehmeier
Additional Information:
Study ID Numbers: 019-01-03-CR; SEACOAST
Study Start Date: April 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082251
Other Dyslipidemia Studies:
1. Look AHEAD: Action for Health in Diabetes
2. Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
3. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
4. Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
5. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
Related Studies:
Other Dyslipidemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
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