Coronary Heart Disease, Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
hypercholesterolemia, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia
Brief summary
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Detailed description
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
Interventions
DRUGpitavastatin
DRUGsimvastatin
Sponsors
Kowa Research Europe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed NK-104-304 (NCT 00309738) * Hypercholesterolemia or combined dyslipidemia * 2 or more risk factors for coronary heart disease (CHD)
Exclusion criteria
* Withdrawn or terminated from NK-104-304 (00309738)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Attaining NCEP LDL-C Target at Week 16 | 16 weeks | 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. |
| Number of Patients Attaining NCEP LDL-C Target at Week 44 | 44 Weeks | Number 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in LDL-C | Baseline to 44 weeks |
Countries
Denmark, Netherlands, Spain, Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg Ptavastatin 4 mg once daily | 121 |
| Simvastatin 40mg/80mg Simvastatin 40 mg or 80 mg once daily | 57 |
| Total | 178 |
Baseline characteristics
| Characteristic | Pitavastatin 4 mg | Simvastatin 40mg/80mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 13 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants | 44 Participants | 142 Participants |
| Age Continuous | 60.4 years STANDARD_DEVIATION 5.8 | 60.8 years STANDARD_DEVIATION 6.52 | 60.5 years STANDARD_DEVIATION 6.02 |
| Sex: Female, Male Female | 39 Participants | 18 Participants | 57 Participants |
| Sex: Female, Male Male | 82 Participants | 39 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 121 | 38 / 57 |
| serious Total, serious adverse events | 4 / 121 | 7 / 57 |
Outcome results
Primary
Number of Patients Attaining NCEP LDL-C Target at Week 16
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.
Time frame: 16 weeks
Population: All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 4 mg | Number of Patients Attaining NCEP LDL-C Target at Week 16 | 98 particpants |
| Simvastatin 40mg/80mg | Number of Patients Attaining NCEP LDL-C Target at Week 16 | 45 particpants |
Primary
Number of Patients Attaining NCEP LDL-C Target at Week 44
Number 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.
Time frame: 44 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 4 mg | Number of Patients Attaining NCEP LDL-C Target at Week 44 | 94 Participants |
| Simvastatin 40mg/80mg | Number of Patients Attaining NCEP LDL-C Target at Week 44 | 42 Participants |
Secondary
Percent Change From Baseline in LDL-C
Time frame: Baseline to 44 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg | Percent Change From Baseline in LDL-C | -41.81 percent change | Standard Deviation 15.13 |
| Simvastatin 40mg/80mg | Percent Change From Baseline in LDL-C | -41.37 percent change | Standard Deviation 16.425 |