Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients (NCT NCT00257686)
NCT ID: NCT00257686
Last Updated: 2010-03-16
Results Overview
Percent change from baseline in low density cholesterol (LDL-C)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
962 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2010-03-16
Participant Flow
Participant milestones
| Measure |
Pitavastatin 1 mg
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
Pravastatin 40 mg once daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
209
|
108
|
226
|
99
|
216
|
104
|
|
Overall Study
Safety Population
|
207
|
103
|
224
|
96
|
210
|
102
|
|
Overall Study
COMPLETED
|
188
|
89
|
208
|
88
|
194
|
95
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
18
|
11
|
22
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
Baseline characteristics by cohort
| Measure |
Pitavastatin 1 mg
n=207 Participants
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
n=103 Participants
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
n=224 Participants
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
n=96 Participants
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
n=210 Participants
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
n=102 Participants
Pravastatin 40 mg once daily
|
Total
n=942 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
207 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
210 Participants
n=31 Participants
|
102 Participants
n=30 Participants
|
942 Participants
n=3 Participants
|
|
Age Continuous
|
70.0 years
STANDARD_DEVIATION 4.60 • n=99 Participants
|
70.5 years
STANDARD_DEVIATION 4.61 • n=107 Participants
|
70.5 years
STANDARD_DEVIATION 4.49 • n=206 Participants
|
69.9 years
STANDARD_DEVIATION 4.51 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 4.10 • n=31 Participants
|
70.2 years
STANDARD_DEVIATION 4.94 • n=30 Participants
|
70.2 years
STANDARD_DEVIATION 4.49 • n=3 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
121 Participants
n=31 Participants
|
42 Participants
n=30 Participants
|
507 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
60 Participants
n=30 Participants
|
435 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPercent change from baseline in low density cholesterol (LDL-C)
Outcome measures
| Measure |
Pitavastatin 1 mg
n=207 Participants
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
n=103 Participants
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
n=224 Participants
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
n=96 Participants
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
n=210 Participants
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
n=102 Participants
Pravastatin 40 mg once daily
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C
|
-31.43 Percent change
Standard Deviation 11.833
|
-22.41 Percent change
Standard Deviation 14.051
|
-38.99 Percent change
Standard Deviation 13.069
|
-28.83 Percent change
Standard Deviation 11.054
|
-44.31 Percent change
Standard Deviation 13.695
|
-33.98 Percent change
Standard Deviation 14.299
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPercent change from baseline in total cholesterol (TC)
Outcome measures
| Measure |
Pitavastatin 1 mg
n=207 Participants
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
n=103 Participants
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
n=224 Participants
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
n=96 Participants
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
n=210 Participants
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
n=102 Participants
Pravastatin 40 mg once daily
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in TC
|
-22.19 Percent change
Standard Deviation 8.899
|
-15.34 Percent change
Standard Deviation 11.037
|
-26.68 Percent change
Standard Deviation 9.429
|
-20.61 Percent change
Standard Deviation 8.426
|
-30.75 Percent change
Standard Deviation 10.461
|
-24.07 Percent change
Standard Deviation 10.907
|
Adverse Events
Pitavastatin 1 mg
Serious events: 1 serious events
Other events: 59 other events
Deaths: 0 deaths
Pravastatin 10 mg
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Pitavastatin 2 mg
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Pravastatin 20 mg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Pitavastatin 4 mg
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Pravastatin 40 mg
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pitavastatin 1 mg
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
Pravastatin 40 mg once daily
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.98%
1/102
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.48%
1/210
|
0.00%
0/102
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.98%
1/102
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.98%
1/102
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/207
|
0.00%
0/103
|
0.45%
1/224
|
0.00%
0/96
|
0.00%
0/210
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.48%
1/210
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.48%
1/210
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.48%
1/210
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
1.0%
1/96
|
0.00%
0/210
|
0.00%
0/102
|
|
Nervous system disorders
Cerebral thrombosis
|
0.48%
1/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.00%
0/102
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/207
|
0.00%
0/103
|
0.45%
1/224
|
0.00%
0/96
|
0.00%
0/210
|
0.00%
0/102
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.98%
1/102
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/207
|
0.00%
0/103
|
0.00%
0/224
|
0.00%
0/96
|
0.00%
0/210
|
0.98%
1/102
|
Other adverse events
| Measure |
Pitavastatin 1 mg
Pitavastatin 1 mg once daily
|
Pravastatin 10 mg
Pravastatin 10 mg once daily
|
Pitavastatin 2 mg
Pitavastatin 2 mg once daily
|
Pravastatin 20 mg
Pravastatin 20 mg once daily
|
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
|
Pravastatin 40 mg
Pravastatin 40 mg once daily
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.2%
15/207
|
5.8%
6/103
|
7.1%
16/224
|
5.2%
5/96
|
9.0%
19/210
|
6.9%
7/102
|
|
Infections and infestations
Influenza
|
3.4%
7/207
|
5.8%
6/103
|
7.1%
16/224
|
6.2%
6/96
|
9.0%
19/210
|
6.9%
7/102
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
3/207
|
3.9%
4/103
|
0.89%
2/224
|
1.0%
1/96
|
1.4%
3/210
|
2.9%
3/102
|
|
Gastrointestinal disorders
Constipation
|
4.8%
10/207
|
4.9%
5/103
|
2.7%
6/224
|
4.2%
4/96
|
4.3%
9/210
|
2.9%
3/102
|
|
Gastrointestinal disorders
Nausea
|
2.4%
5/207
|
4.9%
5/103
|
2.7%
6/224
|
1.0%
1/96
|
1.4%
3/210
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
3/207
|
2.9%
3/103
|
4.9%
11/224
|
2.1%
2/96
|
1.9%
4/210
|
2.0%
2/102
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
6/207
|
2.9%
3/103
|
4.0%
9/224
|
1.0%
1/96
|
1.4%
3/210
|
2.0%
2/102
|
|
Nervous system disorders
Headache
|
3.9%
8/207
|
2.9%
3/103
|
4.0%
9/224
|
4.2%
4/96
|
1.9%
4/210
|
2.0%
2/102
|
|
General disorders
Fatigue
|
0.97%
2/207
|
3.9%
4/103
|
0.00%
0/224
|
0.00%
0/96
|
1.9%
4/210
|
0.00%
0/102
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60