Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NER 500; ASA run-in, ASA coadmin | Experimental | 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) |
|
| NER 500; ASA Pbo run-in, ASA coadmin | Experimental | 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) |
|
| NER 500; ASA Pbo run-in, ASA Pbo coadmin | Experimental | 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) |
|
| NER 1000; ASA run-in, ASA coadmin | Experimental | 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) |
|
| NER 1000; ASA Pbo run-in, ASA coadmin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin extended-release (NER) | Drug | Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment | 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. | From Baseline to end of Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | The maximum severity of flushing events subjects experienced during 4 weeks 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roopal Thakkar, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19331435 | Result | 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. |
Not provided
Not provided
This study had a 1-week run-in (acetylsalicylic acid [ASA] 325 mg or ASA placebo [Pbo] once daily) prior to 4 weeks of niacin extended-release (NER) plus ASA/ASA Pbo coadministration. Ten of 277 randomized subjects discontinued before run-in due to withdrawal of consent (4), lost to follow-up (4), protocol violation (1), and other (1).
Participants were enrolled at 47 study sites in the United States between February and April, 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NER 500; ASA run-in, ASA Coadmin | Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks) |
| FG001 | NER 500; ASA Pbo run-in, ASA Coadmin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
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) |
|
| NER 1000; ASA Pbo run-in, ASA Pbo coadmin | Experimental | 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) |
|
|
| aspirin (ASA) | Drug | 325 mg tablets administered once daily |
|
|
| aspirin placebo (ASA Pbo) | Drug | Tablets administered once daily |
|
|
| 4 weeks |
| Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily. | 4 weeks |
| Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe. | 4 weeks |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Tucson | Arizona | 85710 | United States |
| Tucson | Arizona | 85712 | United States |
| Anaheim | California | 92801 | United States |
| Los Angeles | California | 90057 | United States |
| Newport Beach | California | 92660 | United States |
| Stockton | California | 95204 | United States |
| Vista | California | 90057 | United States |
| Westlake Village | California | 91361 | United States |
| Coral Gables | Florida | 33134 | United States |
| Jacksonville | Florida | 32259 | United States |
| Miami | Florida | 33186 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| West Palm Beach | Florida | 33407 | United States |
| North Dartmouth | Massachusetts | 02747 | United States |
| Rochester | New York | 14609 | United States |
| Charlotte | North Carolina | 28262 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Penndel | Pennsylvania | 19047 | United States |
| Johnston | Rhode Island | 02919 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Colleyville | Texas | 76034 | United States |
| Houston | Texas | 77074 | United States |
| San Antonio | Texas | 78229 | United States |
Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks) |
| FG002 | 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 (4 weeks) |
| FG003 | NER 1000; ASA run-in; ASA Coadmin | Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks) |
| FG004 | NER 1000; ASA Pbo run-in, ASA Coadmin | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks) |
| FG005 | 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 (4 weeks) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Coadministration Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NER 500; ASA run-in, ASA Coadmin | Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks) |
| BG001 | NER 500; ASA Pbo run-in, ASA Coadmin | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks) |
| BG002 | 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 (4 weeks) |
| BG003 | NER 1000; ASA run-in, ASA Coadmin | Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks) |
| BG004 | NER 1000; ASA Pbo run-in, ASA Coadmin | Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks) |
| BG005 | 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 (4 weeks) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Includes only those subjects who entered the coadministration period and received at least one dose of study medication. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Includes only those subjects who entered the coadministration period and received at least one dose of study medication. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Includes only those subjects who entered the coadministration period and received at least one dose of study medication. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment | 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. | All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251). | Posted | Number | Percentage of Subjects | From Baseline to end of Week 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | The maximum severity of flushing events subjects experienced during 4 weeks 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. | All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251). | Posted | Number | Percentage of Subjects | 4 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily. | All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251). | Posted | Mean | Standard Deviation | Scores on a Scale | 4 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment | Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe. | All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251). | Posted | Mean | Standard Deviation | Number of Events per Subject per Week | 4 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Any Acetylsalicylic Acid | Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration. | 1 | 119 | ||||
| EG001 | No Acetylsalicylic Acid | Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration. | 1 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal ulcer | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10-1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
Provide Abbott at least sixty (60) days prior to submission for review, Abbott shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Specialist | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009525 | Niacin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Other |
|
| Male |
|
| None/mild |
|
| Moderate |
|
| Severe |
|
| Very severe |
|
|
|
|