Trial Outcomes & Findings for Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood (NCT NCT00300456)
NCT ID: NCT00300456
Last Updated: 2009-06-03
Results Overview
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
657 participants
Primary outcome timeframe
Baseline to 12 Weeks (Final Visit)
Results posted on
2009-06-03
Participant Flow
Seven subjects were randomized but never treated: 2 were taking a prohibited concomitant medication, 1 did not meet the entry criteria for lipid levels, 1 had an abnormal baseline electrocardiogram, 1 was unable to swallow pills, and 2 withdrew consent.
Participant milestones
| Measure |
ABT-335 + 20 mg Simvastatin
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Simvastatin
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
119
|
118
|
119
|
119
|
116
|
59
|
|
Overall Study
COMPLETED
|
103
|
102
|
98
|
105
|
99
|
48
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
21
|
14
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Baseline characteristics by cohort
| Measure |
ABT-335 + 20 mg Simvastatin
n=119 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=118 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=119 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=119 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=116 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=59 Participants
80 mg simvastatin monotherapy once daily
|
Total
n=650 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
551 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
99 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
332 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
318 Participants
n=8 Participants
|
|
Region of Enrollment
North America
|
119 participants
n=5 Participants
|
118 participants
n=7 Participants
|
119 participants
n=5 Participants
|
119 participants
n=4 Participants
|
116 participants
n=21 Participants
|
59 participants
n=8 Participants
|
650 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=113 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=111 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=113 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=116 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=112 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=56 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Triglycerides From Baseline to Final Visit
|
-37.4 percent change
Standard Error 2.75
|
-42.7 percent change
Standard Error 2.77
|
-31.7 percent change
Standard Error 2.74
|
-14.2 percent change
Standard Error 2.71
|
-22.4 percent change
Standard Error 2.76
|
-20.2 percent change
Standard Error 3.82
|
PRIMARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=105 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=106 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=107 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=114 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=102 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=52 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
|
17.8 percent change
Standard Error 1.86
|
18.9 percent change
Standard Error 1.86
|
16.2 percent change
Standard Error 1.85
|
7.2 percent change
Standard Error 1.80
|
8.5 percent change
Standard Error 1.89
|
6.8 percent change
Standard Error 2.61
|
PRIMARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=109 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=108 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=107 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=116 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=106 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=55 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
|
-24.0 percent change
Standard Error 1.94
|
-25.3 percent change
Standard Error 1.96
|
-4.0 percent change
Standard Error 1.96
|
-22.4 percent change
Standard Error 1.90
|
-31.7 percent change
Standard Error 1.98
|
-40.8 percent change
Standard Error 2.69
|
SECONDARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF
\[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=104 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=104 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=107 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=114 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=103 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=52 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
|
-30.7 percent change
Standard Error 1.48
|
-35.0 percent change
Standard Error 1.48
|
-17.3 percent change
Standard Error 1.46
|
-24.4 percent change
Standard Error 1.43
|
-35.9 percent change
Standard Error 1.49
|
-40.6 percent change
Standard Error 2.06
|
SECONDARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF
\[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=109 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=111 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=110 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=112 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=110 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=54 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit
|
-38.9 percent change
Standard Error 4.06
|
-51.1 percent change
Standard Error 4.03
|
-36.9 percent change
Standard Error 4.04
|
-19.2 percent change
Standard Error 4.04
|
-35.7 percent change
Standard Error 4.06
|
-30.0 percent change
Standard Error 5.66
|
SECONDARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF
\[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=112 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=111 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=113 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=116 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=112 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=56 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
|
-23.9 percent change
Standard Error 1.20
|
-27.1 percent change
Standard Error 1.21
|
-12.4 percent change
Standard Error 1.20
|
-19.8 percent change
Standard Error 1.19
|
-30.0 percent change
Standard Error 1.21
|
-33.6 percent change
Standard Error 1.67
|
SECONDARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF
\[(Week 12 Apo B minus baseline Apo B)/baseline Apo B\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=109 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=110 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=112 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=113 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=112 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=54 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
|
-29.5 percent change
Standard Error 1.47
|
-31.2 percent change
Standard Error 1.47
|
-17.6 percent change
Standard Error 1.45
|
-22.9 percent change
Standard Error 1.45
|
-32.7 percent change
Standard Error 1.46
|
-38.9 percent change
Standard Error 2.05
|
SECONDARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF
\[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Simvastatin
n=111 Participants
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
n=110 Participants
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
n=112 Participants
ABT-335 monotherapy once daily
|
20 mg Simvastatin
n=113 Participants
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
n=112 Participants
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
n=54 Participants
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
|
-26.8 percent change
Inter-Quartile Range 48.27 • Interval -40.9 to 8.2
|
-32.1 percent change
Inter-Quartile Range 48.70 • Interval -51.5 to 9.4
|
-15.8 percent change
Inter-Quartile Range 48.01 • Interval -42.5 to 30.9
|
-11.4 percent change
Inter-Quartile Range 48.18 • Interval -36.0 to 21.4
|
-14.8 percent change
Inter-Quartile Range 48.25 • Interval -40.8 to 11.2
|
-19.8 percent change
Inter-Quartile Range 67.84 • Interval -36.0 to 22.6
|
Adverse Events
ABT-335 + 20 mg Simvastatin
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
ABT-335 + 40 mg Simvastatin
Serious events: 3 serious events
Other events: 72 other events
Deaths: 0 deaths
ABT-335
Serious events: 6 serious events
Other events: 67 other events
Deaths: 0 deaths
20 mg Simvastatin
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
40 mg Simvastatin
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
80 mg Simvastatin
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 + 20 mg Simvastatin
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Simvastatin
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.84%
1/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/119
|
0.85%
1/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.84%
1/119
|
0.00%
0/116
|
0.00%
0/59
|
|
General disorders
Chest pain
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
1.7%
1/59
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
1.7%
1/59
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/119
|
0.85%
1/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Psychiatric disorders
Major depression
|
0.00%
0/119
|
0.85%
1/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.86%
1/116
|
0.00%
0/59
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.86%
1/116
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Vascular disorders
Arterial hemorrhage
|
0.00%
0/119
|
0.00%
0/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
Other adverse events
| Measure |
ABT-335 + 20 mg Simvastatin
ABT-335 + 20 mg simvastatin combination therapy once daily
|
ABT-335 + 40 mg Simvastatin
ABT-335 + 40 mg simvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Simvastatin
20 mg simvastatin monotherapy once daily
|
40 mg Simvastatin
40 mg simvastatin monotherapy once daily
|
80 mg Simvastatin
80 mg simvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.84%
1/119
|
4.2%
5/118
|
1.7%
2/119
|
2.5%
3/119
|
6.9%
8/116
|
1.7%
1/59
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
3/119
|
1.7%
2/118
|
0.00%
0/119
|
1.7%
2/119
|
3.4%
4/116
|
0.00%
0/59
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
5/119
|
2.5%
3/118
|
5.0%
6/119
|
3.4%
4/119
|
5.2%
6/116
|
5.1%
3/59
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
2/119
|
0.85%
1/118
|
0.84%
1/119
|
0.00%
0/119
|
4.3%
5/116
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal pain
|
0.84%
1/119
|
3.4%
4/118
|
2.5%
3/119
|
0.84%
1/119
|
0.86%
1/116
|
0.00%
0/59
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
4/119
|
1.7%
2/118
|
2.5%
3/119
|
0.84%
1/119
|
1.7%
2/116
|
3.4%
2/59
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/119
|
3.4%
4/118
|
5.0%
6/119
|
2.5%
3/119
|
2.6%
3/116
|
1.7%
1/59
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
2/119
|
4.2%
5/118
|
4.2%
5/119
|
4.2%
5/119
|
7.8%
9/116
|
6.8%
4/59
|
|
General disorders
Dyspepsia
|
4.2%
5/119
|
5.9%
7/118
|
6.7%
8/119
|
2.5%
3/119
|
5.2%
6/116
|
1.7%
1/59
|
|
Gastrointestinal disorders
Nausea
|
2.5%
3/119
|
4.2%
5/118
|
4.2%
5/119
|
3.4%
4/119
|
4.3%
5/116
|
1.7%
1/59
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/119
|
1.7%
2/118
|
1.7%
2/119
|
0.84%
1/119
|
0.86%
1/116
|
3.4%
2/59
|
|
General disorders
Fatigue
|
0.00%
0/119
|
1.7%
2/118
|
3.4%
4/119
|
2.5%
3/119
|
0.00%
0/116
|
1.7%
1/59
|
|
General disorders
Pain
|
4.2%
5/119
|
0.85%
1/118
|
5.0%
6/119
|
0.84%
1/119
|
3.4%
4/116
|
0.00%
0/59
|
|
Infections and infestations
Influenza
|
2.5%
3/119
|
2.5%
3/118
|
0.00%
0/119
|
1.7%
2/119
|
3.4%
4/116
|
3.4%
2/59
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
9/119
|
7.6%
9/118
|
5.9%
7/119
|
9.2%
11/119
|
3.4%
4/116
|
1.7%
1/59
|
|
Infections and infestations
Sinusitis
|
2.5%
3/119
|
5.1%
6/118
|
2.5%
3/119
|
0.00%
0/119
|
2.6%
3/116
|
0.00%
0/59
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/119
|
6.8%
8/118
|
5.9%
7/119
|
5.0%
6/119
|
9.5%
11/116
|
5.1%
3/59
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/119
|
0.00%
0/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
3.4%
2/59
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
5/119
|
1.7%
2/118
|
0.84%
1/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
4/119
|
1.7%
2/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Investigations
Blood creatine phosphokinase increased
|
3.4%
4/119
|
0.85%
1/118
|
0.00%
0/119
|
0.84%
1/119
|
2.6%
3/116
|
3.4%
2/59
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
7/119
|
5.9%
7/118
|
2.5%
3/119
|
6.7%
8/119
|
5.2%
6/116
|
3.4%
2/59
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
10/119
|
3.4%
4/118
|
7.6%
9/119
|
6.7%
8/119
|
7.8%
9/116
|
3.4%
2/59
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
6/119
|
2.5%
3/118
|
5.0%
6/119
|
5.0%
6/119
|
5.2%
6/116
|
1.7%
1/59
|
|
Nervous system disorders
Dizziness
|
3.4%
4/119
|
0.00%
0/118
|
4.2%
5/119
|
2.5%
3/119
|
0.86%
1/116
|
3.4%
2/59
|
|
Nervous system disorders
Headache
|
9.2%
11/119
|
21.2%
25/118
|
15.1%
18/119
|
11.8%
14/119
|
20.7%
24/116
|
8.5%
5/59
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/119
|
0.00%
0/118
|
2.5%
3/119
|
0.84%
1/119
|
1.7%
2/116
|
3.4%
2/59
|
|
Nervous system disorders
Sinus headache
|
1.7%
2/119
|
1.7%
2/118
|
4.2%
5/119
|
0.84%
1/119
|
3.4%
4/116
|
0.00%
0/59
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/119
|
3.4%
4/118
|
0.00%
0/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
4/119
|
5.9%
7/118
|
2.5%
3/119
|
4.2%
5/119
|
4.3%
5/116
|
5.1%
3/59
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
4/119
|
0.00%
0/118
|
1.7%
2/119
|
0.00%
0/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
5/119
|
1.7%
2/118
|
3.4%
4/119
|
0.84%
1/119
|
0.00%
0/116
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
4/119
|
2.5%
3/118
|
2.5%
3/119
|
0.84%
1/119
|
1.7%
2/116
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.5%
3/119
|
0.85%
1/118
|
1.7%
2/119
|
1.7%
2/119
|
3.4%
4/116
|
1.7%
1/59
|
|
Vascular disorders
Hypertension
|
0.00%
0/119
|
2.5%
3/118
|
0.00%
0/119
|
0.00%
0/119
|
1.7%
2/116
|
3.4%
2/59
|
Additional Information
Medical Information Specialist
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.
- Publication restrictions are in place
Restriction type: OTHER