Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
NCT ID: NCT00626392
Last Updated: 2009-09-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2008-02-29
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
NCT00630877
Role of Prostaglandins on Niacin-Induced Flushing
NCT00930839
Effects of Psyllium on Niacin Tolerability
NCT03370848
Biosynthesis of PGD2 in Vivo
NCT01275300
Alternative Options to Minimize Niacin-Induced Flushing
NCT00895193
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NER 500; ASA run-in, ASA coadmin
Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)
325 mg tablets administered once daily
NER 500; ASA Pbo run-in, ASA coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)
325 mg tablets administered once daily
aspirin placebo (ASA Pbo)
Tablets administered once daily
NER 500; ASA Pbo run-in, ASA Pbo coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 500 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin placebo (ASA Pbo)
Tablets administered once daily
NER 1000; ASA run-in, ASA coadmin
Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)
325 mg tablets administered once daily
NER 1000; ASA Pbo run-in, ASA coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)
325 mg tablets administered once daily
aspirin placebo (ASA Pbo)
Tablets administered once daily
NER 1000; ASA Pbo run-in, ASA Pbo coadmin
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\[NER\], 1000 mg starting dose), daily during coadministration period (4 weeks)
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin placebo (ASA Pbo)
Tablets administered once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
niacin extended-release (NER)
Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period
aspirin (ASA)
325 mg tablets administered once daily
aspirin placebo (ASA Pbo)
Tablets administered once daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.
* Have dyslipidemia as demonstrated by laboratory results.
Exclusion Criteria
* Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate \[GFR\] \< 30 mL/minute, as calculated from creatinine clearance).
* Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.
* Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.
* Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.
* Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary).
* Have a systolic blood pressure measurement of \> 180 mmHg or a diastolic blood pressure measurement of \> 110 mmHg at the Screening or Baseline Visit.
* Have active gout or uric acid \>/= 11 mg/dL.
* Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) values \>/= 1.3 times the upper limit of normal (ULN) at the Screening Visit.
* Have creatine phosphokinase (CPK) \>/= 3 x ULN at the Screening Visit.
* Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit.
* Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abbott
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roopal Thakkar, MD
Role: STUDY_DIRECTOR
Abbott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Stockton, California, United States
Vista, California, United States
Westlake Village, California, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
North Dartmouth, Massachusetts, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Penndel, Pennsylvania, United States
Johnston, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Colleyville, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M10-241
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.