Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00630877 |
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 |
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 |
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Nicotinic Acids Metabolic Diseases Aspirin Flushing |
Metabolic disorder Niacin Dyslipidemias Lipid Metabolism Disorders |
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 |