Trial Outcomes & Findings for Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors (NCT NCT00344175)
NCT ID: NCT00344175
Last Updated: 2010-02-02
Results Overview
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
COMPLETED
PHASE3
178 participants
16 weeks
2010-02-02
Participant Flow
Patients with primary hypercholesterolemia or combined dyslipidemia, who have satisfied the inclusion/exclusion criteria of the core study, and completed the core study were eligible for this study.
Participant milestones
| Measure |
Pitavastatin 4 mg
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
57
|
|
Overall Study
COMPLETED
|
109
|
47
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
Baseline characteristics by cohort
| Measure |
Pitavastatin 4 mg
n=121 Participants
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=57 Participants
Simvastatin 40 mg or 80 mg once daily
|
Total
n=178 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
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age Continuous
|
60.4 years
STANDARD_DEVIATION 5.80 • n=99 Participants
|
60.8 years
STANDARD_DEVIATION 6.52 • n=107 Participants
|
60.5 years
STANDARD_DEVIATION 6.02 • n=206 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Outcome measures
| Measure |
Pitavastatin 4 mg
n=108 Participants
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=52 Participants
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Number of Patients Attaining NCEP LDL-C Target at Week 16
|
98 particpants
|
45 particpants
|
PRIMARY outcome
Timeframe: 44 WeeksNumber of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
Outcome measures
| Measure |
Pitavastatin 4 mg
n=108 Participants
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=52 Participants
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Number of Patients Attaining NCEP LDL-C Target at Week 44
|
94 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Baseline to 44 weeksOutcome measures
| Measure |
Pitavastatin 4 mg
n=108 Participants
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=52 Participants
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Percent Change From Baseline in LDL-C
|
-41.81 percent change
Standard Deviation 15.130
|
-41.37 percent change
Standard Deviation 16.425
|
Adverse Events
Pitavastatin 4 mg
Simvastatin 40mg/80mg
Serious adverse events
| Measure |
Pitavastatin 4 mg
n=121 participants at risk
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=57 participants at risk
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/121
|
1.8%
1/57
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/121
|
1.8%
1/57
|
|
Cardiac disorders
Myocardial ischaemia
|
0.83%
1/121
|
0.00%
0/57
|
|
Eye disorders
Cataract
|
0.83%
1/121
|
0.00%
0/57
|
|
General disorders
Non-cardiac chest pain
|
0.83%
1/121
|
0.00%
0/57
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.83%
1/121
|
0.00%
0/57
|
|
Infections and infestations
Bronchitis
|
0.83%
1/121
|
0.00%
0/57
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/121
|
1.8%
1/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/121
|
1.8%
1/57
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/121
|
1.8%
1/57
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/121
|
1.8%
1/57
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/121
|
1.8%
1/57
|
Other adverse events
| Measure |
Pitavastatin 4 mg
n=121 participants at risk
Ptavastatin 4 mg once daily
|
Simvastatin 40mg/80mg
n=57 participants at risk
Simvastatin 40 mg or 80 mg once daily
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.8%
24/121
|
26.3%
15/57
|
|
Infections and infestations
Influenza
|
5.8%
7/121
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
10/121
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
5/121
|
12.3%
7/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
3/121
|
7.0%
4/57
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
6/121
|
1.8%
1/57
|
|
Nervous system disorders
Headache
|
1.7%
2/121
|
8.8%
5/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60