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A Placebo-Controlled Prospective Study to Evaluate Flushing in Subjects Administered Niaspan® Plus Aspirin for Six Weeks
This study has been completed.
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00630877
  Purpose

To evaluate flushing symptoms after receiving Niaspan and aspirin daily over a 6-week period.


Condition Intervention Phase
Dyslipidemia
Drug: Niaspan plus aspirin
Drug: Niaspan plus aspirin placebo
Drug: Niaspan placebo/aspirin placebo
Phase III

Drug Information available for: Acetylsalicylic acid Niacin Niacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Parallel, Multicenter Placebo-Controlled Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus Daily for Six Weeks

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Daily flushing events after study drug administration [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in total cholesterol, HDL, non-HDL, LDL, TG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety assessments: evaluation of adverse events, laboratory parameters, vital signs and physical examination [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: February 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator Drug: Niaspan plus aspirin
Niaspan 2000 mg daily/aspirin 325 mg daily for 6 weeks
B: Placebo Comparator Drug: Niaspan plus aspirin placebo
Niaspan 2000 mg daily plus aspirin placebo daily for 6 weeks
C: Placebo Comparator Drug: Niaspan placebo/aspirin placebo
1 tablet daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically 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 glycosylated hemoglobin (HbA1c) >= 9.0%.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630877

  Show 41 Study Locations
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Abbott ( Scott Krause, Clinical Research AD )
Study ID Numbers: M10-229
Study First Received: February 29, 2008
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00630877  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Nicotinic Acids
Metabolic Diseases
Aspirin
Flushing
Metabolic disorder
Niacin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Sensory System Agents
Therapeutic Uses
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Micronutrients
Vitamin B Complex
Growth Substances
Antilipemic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009