Trial Outcomes & Findings for Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels (NCT NCT00249249)
NCT ID: NCT00249249
Last Updated: 2010-01-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
830 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2010-01-12
Participant Flow
First Patient In: 4 October 2005 Last Patient Out: 8 November 2006 A total of 39 investigators at 39 sites in India, Russia, Spain and Denmark received IRB approval to participate in this study and screened and randomized patients.
Patients with major protocol violations were identified programmatically prior to unblinding to determine who should be excluded from the per protocol population.
Participant milestones
| Measure |
Pitavastatin 2 mg QD
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
321
|
103
|
303
|
103
|
|
Overall Study
Safety Population
|
316
|
102
|
300
|
103
|
|
Overall Study
COMPLETED
|
301
|
98
|
288
|
100
|
|
Overall Study
NOT COMPLETED
|
20
|
5
|
15
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Baseline characteristics by cohort
| Measure |
Pitavastatin 2 mg QD
n=316 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=102 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=300 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=103 Participants
Atorvastatin 20 mg daily
|
Total
n=821 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
|
|
Age, Categorical
Between 18 and 65 years
|
219 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
574 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Age Continuous
|
58.4 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 8.63 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
58.3 years
STANDARD_DEVIATION 9.58 • n=21 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
443 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
378 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=301 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
|
-37.89 percent change
Standard Deviation 13.841
|
-38.76 percent change
Standard Deviation 14.582
|
-45.5 percent change
Standard Deviation 14.005
|
-43.9 percent change
Standard Deviation 15.853
|
SECONDARY outcome
Timeframe: Baseline to 12 WeeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Percent change in total cholesterol from baseline to Week 12
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=301 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (TC)
|
-27.57 percent change
Standard Deviation 10.359
|
-28.92 percent change
Standard Deviation 11.441
|
-33.09 percent change
Standard Deviation 10.732
|
-32.99 percent change
Standard Deviation 12.073
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=301 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
|
4.28 percent change
Standard Deviation 16.501
|
3.42 percent change
Standard Deviation 16.820
|
4.93 percent change
Standard Deviation 16.629
|
2.63 percent change
Standard Deviation 13.803
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Ratio of mean total cholesterol to mean HDL-C at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=301 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
TC:HDL-C Ratio
|
4.018 ratio
Standard Deviation 1.1294
|
3.763 ratio
Standard Deviation 0.8667
|
3.583 ratio
Standard Deviation 1.0961
|
3.79 ratio
Standard Deviation 1.2052
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
mean triglycerides at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=302 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Triglycerides (TG)
|
132.4 mg/dL
Standard Deviation 59.82
|
122.2 mg/dL
Standard Deviation 57.09
|
124.4 mg/dL
Standard Deviation 64.91
|
122.6 mg/dL
Standard Deviation 59.01
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Ratio of non-HDL to HDL at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=234 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=82 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=250 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=82 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Non-HDL:HDL Ratio
|
2.993 (MEAN)
Standard Deviation 1.0935
|
2.770 (MEAN)
Standard Deviation 0.8846
|
2.601 (MEAN)
Standard Deviation 1.0961
|
2.710 (MEAN)
Standard Deviation 1.1771
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Apolipoprotein B at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=295 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=285 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=99 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Apolipoprotein B (Apo B)
|
114.5 mg/dL
Standard Deviation 23.36
|
111.1 mg/dL
Standard Deviation 25.12
|
102.3 mg/dL
Standard Deviation 22.04
|
102.4 mg/dL
Standard Deviation 22.13
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Apolipoprotein-A1 at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=295 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=285 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=99 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Apolipoprotein-A1 (Apo-A1)
|
164.6 mg/dL
Standard Deviation 29.10
|
166 mg/dL
Standard Deviation 26.8
|
166.9 mg/dL
Standard Deviation 28.01
|
160.9 mg/dL
Standard Deviation 26.58
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Ratio of Apo-B to Apo-A1 at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=295 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=285 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=99 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Apo-B:Apo-A1 Ratio
|
0.72 ratio
Standard Deviation 0.228
|
0.68 ratio
Standard Deviation 0.181
|
0.64 ratio
Standard Deviation 0.198
|
0.66 ratio
Standard Deviation 0.205
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
high sensitivity C-reactive protein (hs-CRP) at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=301 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=97 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=288 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks
|
2.87 mg/L
Standard Deviation 5.101
|
2.39 mg/L
Standard Deviation 3.053
|
3.12 mg/L
Standard Deviation 5.186
|
2.56 mg/L
Standard Deviation 2.958
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
oxidized low density lipoprotein at 12 weeks
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=302 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=98 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=289 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=100 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Oxidized LDL at 12 Weeks
|
59.93 U/L
Standard Deviation 14.96
|
58.59 U/L
Standard Deviation 14.679
|
54.32 U/L
Standard Deviation 13.496
|
54.70 U/L
Standard Deviation 17.865
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.
Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)
Outcome measures
| Measure |
Pitavastatin 2 mg QD
n=315 Participants
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=102 Participants
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=298 Participants
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=102 Participants
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
National Cholesterol Education Program [NCEP]LDL-C Target Attainment
|
179 Patients
|
67 Patients
|
232 Patients
|
72 Patients
|
Adverse Events
Pitavastatin 2 mg QD
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Atorvastatin 10 mg QD
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Pitavastatin 4 mg QD
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Atorvastatin 20 mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 2 mg QD
n=316 participants at risk
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=102 participants at risk
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=300 participants at risk
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=103 participants at risk
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
pruritus generalized
|
0.32%
1/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Cardiac disorders
acute myocardial infarction
|
0.32%
1/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.97%
1/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Cardiac disorders
angina unstable
|
0.00%
0/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.98%
1/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.33%
1/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Ear and labyrinth disorders
deafness neurosensory
|
0.00%
0/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.97%
1/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Nervous system disorders
burning sensation
|
0.32%
1/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Nervous system disorders
encephalopathy
|
0.00%
0/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.97%
1/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Pregnancy, puerperium and perinatal conditions
abortion spontaneous
|
0.32%
1/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
Other adverse events
| Measure |
Pitavastatin 2 mg QD
n=316 participants at risk
Pitavastatin 2 mg daily
|
Atorvastatin 10 mg QD
n=102 participants at risk
Atorvastatin 10 mg daily
|
Pitavastatin 4 mg QD
n=300 participants at risk
Pitavastatin 4 mg daily
|
Atorvastatin 20 mg QD
n=103 participants at risk
Atorvastatin 20 mg daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
2.2%
7/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.98%
1/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
1.0%
3/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.00%
0/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Infections and infestations
nasopharyngitis
|
3.2%
10/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
3.9%
4/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
2.7%
8/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
2.9%
3/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
1.6%
5/316
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.98%
1/102
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
2.0%
6/300
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
0.97%
1/103
Safety was assessed for all randomized patients who received at least one dose of study drug (Safety Population). The Safety Population contained 821 patients; 616 were treated with pitavastatin and 205 with atorvastatin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60