Trial Outcomes & Findings for Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood (NCT NCT00639158)
NCT ID: NCT00639158
Last Updated: 2011-06-13
Results Overview
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
COMPLETED
PHASE3
543 participants
Baseline to 12 Weeks (Final Visit)
2011-06-13
Participant Flow
One subject was randomized to the atorvastatin and ezetimibe treatment group and never received study drug.
Participant milestones
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
|
|---|---|---|
|
Overall Study
STARTED
|
272
|
270
|
|
Overall Study
COMPLETED
|
246
|
240
|
|
Overall Study
NOT COMPLETED
|
26
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Baseline characteristics by cohort
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=272 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=270 Participants
|
Total
n=542 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
227 Participants
n=39 Participants
|
206 Participants
n=41 Participants
|
433 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
109 Participants
n=35 Participants
|
|
Age Continuous
|
54.4 years
STANDARD_DEVIATION 11.23 • n=39 Participants
|
56.4 years
STANDARD_DEVIATION 10.67 • n=41 Participants
|
55.4 years
STANDARD_DEVIATION 10.99 • n=35 Participants
|
|
Age Continuous
United States
|
54.4 participants
STANDARD_DEVIATION 11.23 • n=39 Participants
|
56.4 participants
STANDARD_DEVIATION 10.67 • n=41 Participants
|
55.4 participants
STANDARD_DEVIATION 10.99 • n=35 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=39 Participants
|
155 Participants
n=41 Participants
|
298 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=39 Participants
|
115 Participants
n=41 Participants
|
244 Participants
n=35 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 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
|---|---|---|
|
Median Percent Change in Triglycerides From Baseline to Final Visit
|
-57.3 Percent change
Inter-Quartile Range 22.32 • Interval -67.1 to -46.3
|
-39.7 Percent change
Inter-Quartile Range 29.44 • Interval -52.5 to -20.9
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks (Final Visit)Population: All randomized subjects with a baseline high density lipoprotein cholesterol (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 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
|---|---|---|
|
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
|
13.0 Percent change
Standard Error 0.95
|
4.2 Percent change
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks (Final Visit)Population: All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.
\[(Week 12 apoAI minus baseline apoAI)/baseline apoAI\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=248 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=239 Participants
|
|---|---|---|
|
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
|
1.8 Percent change
Standard Error 0.74
|
-1.3 Percent change
Standard Error 0.76
|
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, last observation carried forward.
\[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=261 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
|---|---|---|
|
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
|
-57.8 Percent change
Standard Error 1.87
|
-41.1 Percent change
Standard Error 1.87
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks (Final Visit)Population: All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.
\[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=249 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=242 Participants
|
|---|---|---|
|
Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
|
-42.5 Percent change
Standard Error 1.22
|
-25.3 Percent change
Standard Error 1.23
|
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, last observation carried forward.
\[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
|---|---|---|
|
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
|
-55.6 Percent change
Standard Error 0.94
|
-51.0 Percent change
Standard Error 0.94
|
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, last observation carried forward.
\[(Week 12 apoB minus baseline apoB)/baseline apoB\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=248 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=239 Participants
|
|---|---|---|
|
Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit
|
-49.1 Percent change
Standard Error 0.91
|
-44.7 Percent change
Standard Error 0.93
|
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, last observation carried forward.
\[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP\] x 100
Outcome measures
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=261 Participants
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=262 Participants
|
|---|---|---|
|
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit
|
-52.1 Percent change
Inter-Quartile Range 102.82 • Interval -67.4 to -25.4
|
-40.3 Percent change
Inter-Quartile Range 516.56 • Interval -60.6 to -13.4
|
Adverse Events
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
Serious adverse events
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=272 participants at risk
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=270 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.37%
1/272
|
0.00%
0/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/272
|
0.37%
1/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/272
|
0.37%
1/270
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/272
|
0.37%
1/270
|
|
General disorders
Chest Pain
|
0.37%
1/272
|
0.00%
0/270
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/272
|
0.37%
1/270
|
|
Gastrointestinal disorders
Dyspepsia
|
0.37%
1/272
|
0.00%
0/270
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.37%
1/272
|
0.00%
0/270
|
|
General disorders
Non-Cardiac Chest Pain
|
0.37%
1/272
|
0.00%
0/270
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/272
|
0.37%
1/270
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.37%
1/272
|
0.00%
0/270
|
Other adverse events
| Measure |
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe
n=272 participants at risk
|
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe
n=270 participants at risk
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
6/272
|
3.7%
10/270
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
9/272
|
2.2%
6/270
|
|
General disorders
Fatigue
|
2.2%
6/272
|
3.7%
10/270
|
|
Nervous system disorders
Headache
|
2.2%
6/272
|
3.3%
9/270
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.7%
10/272
|
3.3%
9/270
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
7/272
|
3.7%
10/270
|
|
Gastrointestinal disorders
Nausea
|
1.5%
4/272
|
3.3%
9/270
|
Additional Information
Global Medical Services
Abbott
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