Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin (NCT NCT00309777)
NCT ID: NCT00309777
Last Updated: 2010-01-12
Results Overview
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
857 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2010-01-12
Participant Flow
Subjects were randomized to one of 4 treatment arms based on inclusion/exclusion criteria.
After a 6-8 week run in period when no lipid lowering therapy was allowed, subjects were randomized to one of 4 treatment arms.
Participant milestones
| Measure |
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
315
|
108
|
323
|
111
|
|
Overall Study
Safety Population
|
311
|
107
|
320
|
110
|
|
Overall Study
COMPLETED
|
292
|
99
|
304
|
107
|
|
Overall Study
NOT COMPLETED
|
23
|
9
|
19
|
4
|
Reasons for withdrawal
| Measure |
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
2
|
8
|
1
|
|
Overall Study
Protocol Violation
|
4
|
1
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Baseline characteristics by cohort
| Measure |
Pitavastatin 2 mg
n=311 Participants
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
n=107 Participants
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
n=320 Participants
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
n=110 Participants
Simvastatn 40 mg once daily
|
Total
n=848 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
|
214 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
593 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Age Continuous
|
58.7 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 9.64 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 9.54 • n=4 Participants
|
58.3 years
STANDARD_DEVIATION 9.08 • n=21 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
502 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
346 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPercent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Outcome measures
| Measure |
Pitavastatin 2 mg
n=307 Participants
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
n=107 Participants
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
n=319 Participants
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
n=110 Participants
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
|
-38.99 Percent change
Standard Deviation 14.573
|
-34.97 Percent change
Standard Deviation 15.528
|
-43.97 Percent change
Standard Deviation 14.494
|
-42.84 Percent change
Standard Deviation 15.769
|
SECONDARY outcome
Timeframe: 12 weekPopulation: Full Analysis Set
Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12
Outcome measures
| Measure |
Pitavastatin 2 mg
n=307 Participants
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
n=107 Participants
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
n=319 Participants
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
n=110 Participants
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
|
215 Participants
|
69 Participants
|
253 Participants
|
86 Participants
|
Adverse Events
Pitavastatin 2 mg
Serious events: 3 serious events
Other events: 56 other events
Deaths: 0 deaths
Simvastatin 20 mg
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Pitavastatin 4 mg
Serious events: 4 serious events
Other events: 44 other events
Deaths: 0 deaths
Simvastatin 40 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 2 mg
n=311 participants at risk
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
n=107 participants at risk
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
n=320 participants at risk
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
n=110 participants at risk
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/311
|
0.93%
1/107
|
0.00%
0/320
|
0.00%
0/110
|
|
Cardiac disorders
Pleuropericarditis
|
0.32%
1/311
|
0.00%
0/107
|
0.00%
0/320
|
0.00%
0/110
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.32%
1/311
|
0.00%
0/107
|
0.00%
0/320
|
0.00%
0/110
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/311
|
0.00%
0/107
|
0.31%
1/320
|
0.00%
0/110
|
|
General disorders
Sudden cardiac death
|
0.00%
0/311
|
0.93%
1/107
|
0.00%
0/320
|
0.00%
0/110
|
|
Immune system disorders
Anaphylactic reation
|
0.32%
1/311
|
0.00%
0/107
|
0.00%
0/320
|
0.00%
0/110
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/311
|
0.00%
0/107
|
0.31%
1/320
|
0.00%
0/110
|
|
Infections and infestations
Erysipelas
|
0.00%
0/311
|
0.00%
0/107
|
0.00%
0/320
|
1.8%
2/110
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/311
|
0.00%
0/107
|
0.31%
1/320
|
0.00%
0/110
|
|
Nervous system disorders
Convulsion
|
0.00%
0/311
|
0.00%
0/107
|
0.31%
1/320
|
0.00%
0/110
|
Other adverse events
| Measure |
Pitavastatin 2 mg
n=311 participants at risk
Pitavastatin 2 mg once daily
|
Simvastatin 20 mg
n=107 participants at risk
Simvastatin 20 mg once daily
|
Pitavastatin 4 mg
n=320 participants at risk
Pitavastatin 4 mg once daily
|
Simvastatin 40 mg
n=110 participants at risk
Simvastatn 40 mg once daily
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
1.3%
4/311
|
5.6%
6/107
|
0.31%
1/320
|
0.91%
1/110
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
7/311
|
0.93%
1/107
|
0.94%
3/320
|
0.91%
1/110
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
4/311
|
4.7%
5/107
|
0.94%
3/320
|
0.00%
0/110
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.96%
3/311
|
2.8%
3/107
|
2.2%
7/320
|
0.91%
1/110
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
9/311
|
2.8%
3/107
|
1.9%
6/320
|
2.7%
3/110
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
8/311
|
1.9%
2/107
|
1.9%
6/320
|
0.91%
1/110
|
|
Gastrointestinal disorders
Nausea
|
1.3%
4/311
|
2.8%
3/107
|
1.9%
6/320
|
0.91%
1/110
|
|
Nervous system disorders
Headache
|
3.2%
10/311
|
3.7%
4/107
|
3.4%
11/320
|
1.8%
2/110
|
|
General disorders
Fatigue
|
2.3%
7/311
|
0.93%
1/107
|
0.31%
1/320
|
0.00%
0/110
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60