Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 277
- 主要终点
- Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: aspirin placebo (ASA Pbo) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: aspirin (ASA) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: aspirin (ASA) (Drug)
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)
干预措施: aspirin placebo (ASA Pbo) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: aspirin (ASA) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: aspirin (ASA) (Drug)
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)
干预措施: aspirin placebo (ASA Pbo) (Drug)
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)
干预措施: niacin extended-release (NER) (Drug)
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)
干预措施: aspirin placebo (ASA Pbo) (Drug)
结局指标
主要结局
Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment
时间窗: From Baseline to end of Week 1
The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.
次要结局
- Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment(4 weeks)
- Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment(4 weeks)
- Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment(4 weeks)