Trial Outcomes & Findings for Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood (NCT NCT00300469)
NCT ID: NCT00300469
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
613 participants
Primary outcome timeframe
Baseline to 12 Weeks (Final Visit)
Results posted on
2009-06-03
Participant Flow
Four subjects were randomized but never treated: 2 were randomized but were deemed ineligible, 1 had a history of allergic reactions to statins, and 1 was noncompliant and never received study drug.
Participant milestones
| Measure |
ABT-335 + 20 mg Atorvastatin
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
112
|
113
|
109
|
55
|
|
Overall Study
COMPLETED
|
89
|
89
|
95
|
104
|
95
|
46
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
17
|
9
|
14
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Baseline characteristics by cohort
| Measure |
ABT-335 + 20 mg Atorvastatin
n=110 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=110 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=112 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=113 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=109 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=55 Participants
80 mg atorvastatin monotherapy once daily
|
Total
n=609 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
489 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
119 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
311 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
298 Participants
n=115 Participants
|
|
Region of Enrollment
North America
|
110 participants
n=5 Participants
|
110 participants
n=7 Participants
|
112 participants
n=5 Participants
|
113 participants
n=4 Participants
|
109 participants
n=21 Participants
|
55 participants
n=10 Participants
|
609 participants
n=115 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 (excluding one subject with an extreme outlying value)
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Atorvastatin
n=105 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=102 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=104 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=108 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=105 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=52 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Triglycerides From Baseline to Final Visit
|
-45.6 percent change
Standard Error 3.36
|
-42.1 percent change
Standard Error 3.40
|
-29.6 percent change
Standard Error 3.35
|
-16.5 percent change
Standard Error 3.31
|
-23.2 percent change
Standard Error 3.35
|
-30.4 percent change
Standard Error 4.70
|
PRIMARY outcome
Timeframe: Baseline to 12 Weeks (Final Visit)Population: All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Atorvastatin
n=95 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=91 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=93 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=101 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=92 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=50 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
|
14.0 percent change
Standard Error 2.02
|
12.6 percent change
Standard Error 2.08
|
19.9 percent change
Standard Error 2.04
|
6.3 percent change
Standard Error 1.96
|
5.3 percent change
Standard Error 2.05
|
6.2 percent change
Standard Error 2.75
|
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 (excluding 1 subject with extreme outlying value)
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 20 mg Atorvastatin
n=97 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=96 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=97 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=103 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=95 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=50 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
|
-33.7 percent change
Standard Error 1.91
|
-35.4 percent change
Standard Error 1.93
|
-3.4 percent change
Standard Error 1.90
|
-37.1 percent change
Standard Error 1.85
|
-39.7 percent change
Standard Error 1.92
|
-46.0 percent change
Standard Error 2.61
|
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 Atorvastatin
n=95 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=91 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=93 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=102 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=92 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=50 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
|
-40.8 percent change
Standard Error 1.69
|
-42.5 percent change
Standard Error 1.74
|
-14.8 percent change
Standard Error 1.71
|
-35.7 percent change
Standard Error 1.64
|
-41.7 percent change
Standard Error 1.72
|
-45.2 percent change
Standard Error 2.30
|
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 Atorvastatin
n=103 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=101 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=104 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=107 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=105 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=52 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
|
-48.3 percent change
Standard Error 3.72
|
-53.5 percent change
Standard Error 3.74
|
-36.5 percent change
Standard Error 3.66
|
-26.2 percent change
Standard Error 3.63
|
-35.6 percent change
Standard Error 3.66
|
-38.9 percent change
Standard Error 5.13
|
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 Atorvastatin
n=105 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=102 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=104 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=109 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=105 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=52 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Total Cholesterol From Baseline to Final Visit
|
-32.8 percent change
Standard Error 1.32
|
-34.6 percent change
Standard Error 1.33
|
-10.1 percent change
Standard Error 1.32
|
-29.6 percent change
Standard Error 1.29
|
-33.8 percent change
Standard Error 1.31
|
-38.2 percent change
Standard Error 1.84
|
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 Atorvastatin
n=104 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=101 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=104 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=109 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=104 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=52 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit
|
-37.0 percent change
Standard Error 1.49
|
-37.1 percent change
Standard Error 1.52
|
-12.4 percent change
Standard Error 1.49
|
-32.9 percent change
Standard Error 1.46
|
-35.3 percent change
Standard Error 1.50
|
-40.3 percent change
Standard Error 2.08
|
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 Atorvastatin
n=104 Participants
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
n=101 Participants
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
n=104 Participants
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
n=109 Participants
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
n=104 Participants
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
n=52 Participants
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit
|
-26.2 percent change
Inter-Quartile Range 24.76 • Interval -49.7 to 0.3
|
-42.9 percent change
Inter-Quartile Range 25.11 • Interval -56.4 to -21.2
|
-12.4 percent change
Inter-Quartile Range 24.65 • Interval -41.2 to 42.8
|
-29.6 percent change
Inter-Quartile Range 24.18 • Interval -48.3 to 14.7
|
-30.3 percent change
Inter-Quartile Range 25.08 • Interval -51.7 to -2.4
|
-31.9 percent change
Inter-Quartile Range 34.50 • Interval -57.5 to -3.5
|
Adverse Events
ABT-335 + 20 mg Atorvastatin
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
ABT-335 + 40 mg Atorvastatin
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
ABT-335
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
20 mg Atorvastatin
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
40 mg Atorvastatin
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
80 mg Atorvastatin
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABT-335 + 20 mg Atorvastatin
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/110
|
0.00%
0/110
|
0.89%
1/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.88%
1/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
1.8%
1/55
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.92%
1/109
|
0.00%
0/55
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/110
|
0.91%
1/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/110
|
0.91%
1/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.92%
1/109
|
0.00%
0/55
|
|
Infections and infestations
Parotitis
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.92%
1/109
|
0.00%
0/55
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/110
|
0.91%
1/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
1.8%
1/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/110
|
0.00%
0/110
|
0.89%
1/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Nervous system disorders
Sciatica
|
0.00%
0/110
|
0.00%
0/110
|
0.00%
0/112
|
0.88%
1/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Nervous system disorders
Syncope
|
0.91%
1/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/110
|
0.00%
0/110
|
0.89%
1/112
|
0.00%
0/113
|
0.00%
0/109
|
0.00%
0/55
|
Other adverse events
| Measure |
ABT-335 + 20 mg Atorvastatin
ABT-335 + 20 mg atorvastatin combination therapy once daily
|
ABT-335 + 40 mg Atorvastatin
ABT-335 + 40 mg atorvastatin combination therapy once daily
|
ABT-335
ABT-335 monotherapy once daily
|
20 mg Atorvastatin
20 mg atorvastatin monotherapy once daily
|
40 mg Atorvastatin
40 mg atorvastatin monotherapy once daily
|
80 mg Atorvastatin
80 mg atorvastatin monotherapy once daily
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
3/110
|
1.8%
2/110
|
2.7%
3/112
|
1.8%
2/113
|
1.8%
2/109
|
3.6%
2/55
|
|
Gastrointestinal disorders
Constipation
|
2.7%
3/110
|
3.6%
4/110
|
0.89%
1/112
|
1.8%
2/113
|
0.92%
1/109
|
1.8%
1/55
|
|
Gastrointestinal disorders
Diarrhea
|
5.5%
6/110
|
4.5%
5/110
|
6.2%
7/112
|
4.4%
5/113
|
6.4%
7/109
|
12.7%
7/55
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
3/110
|
2.7%
3/110
|
0.89%
1/112
|
0.88%
1/113
|
3.7%
4/109
|
0.00%
0/55
|
|
Gastrointestinal disorders
Nausea
|
4.5%
5/110
|
7.3%
8/110
|
3.6%
4/112
|
1.8%
2/113
|
5.5%
6/109
|
7.3%
4/55
|
|
General disorders
Fatigue
|
0.91%
1/110
|
1.8%
2/110
|
0.00%
0/112
|
2.7%
3/113
|
5.5%
6/109
|
0.00%
0/55
|
|
General disorders
Edema peripheral
|
1.8%
2/110
|
0.00%
0/110
|
1.8%
2/112
|
0.00%
0/113
|
6.4%
7/109
|
3.6%
2/55
|
|
Infections and infestations
Bronchitis
|
0.00%
0/110
|
0.91%
1/110
|
0.00%
0/112
|
0.00%
0/113
|
0.92%
1/109
|
3.6%
2/55
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/110
|
0.91%
1/110
|
0.89%
1/112
|
0.00%
0/113
|
0.92%
1/109
|
5.5%
3/55
|
|
Infections and infestations
Influenza
|
0.91%
1/110
|
2.7%
3/110
|
0.00%
0/112
|
3.5%
4/113
|
0.92%
1/109
|
1.8%
1/55
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
4/110
|
2.7%
3/110
|
3.6%
4/112
|
3.5%
4/113
|
3.7%
4/109
|
5.5%
3/55
|
|
Infections and infestations
Sinusitis
|
1.8%
2/110
|
4.5%
5/110
|
2.7%
3/112
|
1.8%
2/113
|
1.8%
2/109
|
1.8%
1/55
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
4/110
|
2.7%
3/110
|
8.0%
9/112
|
1.8%
2/113
|
5.5%
6/109
|
0.00%
0/55
|
|
Investigations
Alanine aminotransferase increased
|
5.5%
6/110
|
0.91%
1/110
|
0.89%
1/112
|
0.00%
0/113
|
0.00%
0/109
|
3.6%
2/55
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
6/110
|
0.91%
1/110
|
0.89%
1/112
|
0.00%
0/113
|
0.00%
0/109
|
3.6%
2/55
|
|
Investigations
Blood alkaline phosphatase increased
|
0.91%
1/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
1.8%
2/109
|
3.6%
2/55
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
4/110
|
0.00%
0/110
|
0.00%
0/112
|
0.00%
0/113
|
0.92%
1/109
|
3.6%
2/55
|
|
Investigations
Hepatic enzyme increased
|
3.6%
4/110
|
4.5%
5/110
|
0.89%
1/112
|
0.00%
0/113
|
0.92%
1/109
|
1.8%
1/55
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
3/110
|
1.8%
2/110
|
5.4%
6/112
|
1.8%
2/113
|
5.5%
6/109
|
1.8%
1/55
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
5/110
|
0.91%
1/110
|
4.5%
5/112
|
4.4%
5/113
|
5.5%
6/109
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
4/110
|
3.6%
4/110
|
2.7%
3/112
|
3.5%
4/113
|
3.7%
4/109
|
1.8%
1/55
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
2/110
|
4.5%
5/110
|
2.7%
3/112
|
4.4%
5/113
|
7.3%
8/109
|
5.5%
3/55
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
3/110
|
2.7%
3/110
|
1.8%
2/112
|
3.5%
4/113
|
5.5%
6/109
|
3.6%
2/55
|
|
Nervous system disorders
Dizziness
|
2.7%
3/110
|
6.4%
7/110
|
2.7%
3/112
|
0.88%
1/113
|
3.7%
4/109
|
0.00%
0/55
|
|
Nervous system disorders
Headache
|
11.8%
13/110
|
9.1%
10/110
|
12.5%
14/112
|
15.0%
17/113
|
12.8%
14/109
|
12.7%
7/55
|
|
Nervous system disorders
Somnolence
|
0.91%
1/110
|
0.00%
0/110
|
0.89%
1/112
|
0.00%
0/113
|
0.92%
1/109
|
3.6%
2/55
|
|
Psychiatric disorders
Insomnia
|
0.91%
1/110
|
0.91%
1/110
|
2.7%
3/112
|
0.88%
1/113
|
1.8%
2/109
|
3.6%
2/55
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
1/110
|
0.91%
1/110
|
1.8%
2/112
|
1.8%
2/113
|
0.92%
1/109
|
5.5%
3/55
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.8%
2/110
|
4.5%
5/110
|
2.7%
3/112
|
3.5%
4/113
|
3.7%
4/109
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.91%
1/110
|
0.00%
0/110
|
2.7%
3/112
|
0.88%
1/113
|
0.92%
1/109
|
3.6%
2/55
|
|
General disorders
Pain
|
3.6%
4/110
|
3.6%
4/110
|
2.7%
3/112
|
0.88%
1/113
|
0.92%
1/109
|
3.6%
2/55
|
|
Gastrointestinal disorders
Toothache
|
2.7%
3/110
|
0.91%
1/110
|
3.6%
4/112
|
1.8%
2/113
|
1.8%
2/109
|
1.8%
1/55
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/110
|
1.8%
2/110
|
1.8%
2/112
|
0.00%
0/113
|
0.00%
0/109
|
7.3%
4/55
|
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