Trial Outcomes & Findings for Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin (NCT NCT00630877)
NCT ID: NCT00630877
Last Updated: 2009-10-09
Results Overview
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
COMPLETED
PHASE3
276 participants
Study start to Day 43
2009-10-09
Participant Flow
Subjects were enrolled at 41 sites in the United States between February and June, 2008.
Of the 276 subjects that were randomized, 5 discontinued from the study prior to receiving study drug due to withdrawal of consent (2), death in the family (1), positive pregnancy test (1), and lost to follow up (1).
Participant milestones
| Measure |
NER/ASA
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
90
|
90
|
|
Overall Study
COMPLETED
|
72
|
75
|
80
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
10
|
Reasons for withdrawal
| Measure |
NER/ASA
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Noncompliance
|
2
|
3
|
1
|
|
Overall Study
Protocol violation
|
1
|
0
|
1
|
|
Overall Study
Personal reasons
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
Baseline characteristics by cohort
| Measure |
NER/ASA
n=91 Participants
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
|
NER/ASA Placebo
n=90 Participants
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
n=90 Participants
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
54.1 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 12.74 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 12.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
90 participants
n=7 Participants
|
90 participants
n=5 Participants
|
271 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 2Population: Subjects with stable flushing symptoms from Week 1 to Week 2.
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=174 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
|
0.75 Intraclass correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 to Week 2Population: Subjects with stable flushing symptoms from Week 1 to Week 2.
Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=174 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Test-retest Reliability--maximum Flushing Severity Score
|
0.40 Intraclass correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1Population: m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.
The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=269 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Cross-sectional Construct Validity--mean Flushing Severity Score
|
0.64 Spearman correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1Population: m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.
The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=269 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
|
0.66 Spearman correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 to Week 2Population: m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.
The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=269 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Longitudinal Construct Validity--mean Flushing Severity Score
|
-0.44 Spearman correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 1 to Week 2Population: m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.
The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=269 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Longitudinal Construct Validity--maximum Flushing Severity Score
|
-0.42 Spearman correlation coefficient
|
—
|
—
|
PRIMARY outcome
Timeframe: Study start to Day 43Population: Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.
The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=46 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
n=159 Participants
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Responsiveness--mean Flushing Severity Score
|
-0.51 Units on a scale
|
0.15 Units on a scale
|
—
|
PRIMARY outcome
Timeframe: Study start to Day 43Population: Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.
The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=46 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
n=159 Participants
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
FAST Responsiveness--maximum Flushing Severity Score
|
-1.85 Units on a scale
|
-0.18 Units on a scale
|
—
|
SECONDARY outcome
Timeframe: Week 1 to Week 6Population: m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.
The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.
Outcome measures
| Measure |
Subjects With Stable Flushing Symptoms
n=90 Participants
Subjects whose flushing symptoms remained stable from Week 1 to Week 2
|
NER/ASA Placebo
n=90 Participants
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
n=89 Participants
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
Maximum Severity of Flushing Events Overall During the Study
None
|
26 Percentage of subjects
|
14 Percentage of subjects
|
37 Percentage of subjects
|
|
Maximum Severity of Flushing Events Overall During the Study
Mild
|
23 Percentage of subjects
|
16 Percentage of subjects
|
38 Percentage of subjects
|
|
Maximum Severity of Flushing Events Overall During the Study
None/Mild
|
49 Percentage of subjects
|
30 Percentage of subjects
|
75 Percentage of subjects
|
|
Maximum Severity of Flushing Events Overall During the Study
Moderate
|
34 Percentage of subjects
|
31 Percentage of subjects
|
22 Percentage of subjects
|
|
Maximum Severity of Flushing Events Overall During the Study
Severe
|
17 Percentage of subjects
|
32 Percentage of subjects
|
2 Percentage of subjects
|
|
Maximum Severity of Flushing Events Overall During the Study
Very Severe
|
0 Percentage of subjects
|
7 Percentage of subjects
|
0 Percentage of subjects
|
Adverse Events
NER/ASA
NER/ASA Placebo
NER Placebo/ASA Placebo
Serious adverse events
| Measure |
NER/ASA
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/91 • Number of events 1
|
0.00%
0/90
|
0.00%
0/90
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/91
|
1.1%
1/90 • Number of events 1
|
0.00%
0/90
|
|
Renal and urinary disorders
Right renal cyst
|
0.00%
0/91
|
0.00%
0/90
|
1.1%
1/90 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/91
|
0.00%
0/90
|
1.1%
1/90 • Number of events 1
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis
|
0.00%
0/91
|
0.00%
0/90
|
1.1%
1/90 • Number of events 1
|
Other adverse events
| Measure |
NER/ASA
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
|
NER/ASA Placebo
Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
|
NER Placebo/ASA Placebo
Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/91
|
7.8%
7/90
|
5.6%
5/90
|
|
Gastrointestinal disorders
Nausea
|
4.4%
4/91
|
2.2%
2/90
|
2.2%
2/90
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
3/91
|
2.2%
2/90
|
2.2%
2/90
|
|
General disorders
Fatigue
|
1.1%
1/91
|
2.2%
2/90
|
0.00%
0/90
|
|
General disorders
Peripheral edema
|
2.2%
2/91
|
0.00%
0/90
|
0.00%
0/90
|
|
Infections and infestations
Sinusitis
|
1.1%
1/91
|
2.2%
2/90
|
1.1%
1/90
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
3/91
|
2.2%
2/90
|
2.2%
2/90
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
2/91
|
1.1%
1/90
|
0.00%
0/90
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/91
|
2.2%
2/90
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/91
|
2.2%
2/90
|
0.00%
0/90
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/91
|
0.00%
0/90
|
0.00%
0/90
|
|
Nervous system disorders
Headache
|
3.3%
3/91
|
1.1%
1/90
|
7.8%
7/90
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/91
|
0.00%
0/90
|
2.2%
2/90
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
2/91
|
1.1%
1/90
|
0.00%
0/90
|
|
Vascular disorders
Flushing
|
74.7%
68/91
|
86.7%
78/90
|
62.2%
56/90
|
|
Vascular disorders
Hypertension
|
2.2%
2/91
|
0.00%
0/90
|
0.00%
0/90
|
Additional Information
Medical Information Specialist
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER