Phase 3
Completed N=267
Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Source: ClinicalTrials.gov NCT00626392 ↗Enrolled (actual)
267
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment — 57; 48; 28; 24 Percentage of Subjects — p=0.010
Summary
The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment |
57; 48; 28; 24; 85; 71 | 0.010 sig |
| SECONDARY Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment |
30; 15; 28; 14; 58; 30 | — |
| SECONDARY Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment |
3.1; 5.1 | — |
| SECONDARY Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment |
0.3; 0.8 | — |
Eligibility 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 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 glycosylated hemoglobin (HbA1c) >/= 9.0%.
- Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] 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.
Data sourced from ClinicalTrials.gov (NCT00626392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.