Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Kowa, Hypercholesterolemia, dyslipidemia, pitavastatin, NK-104, Hypercholesterolemia or combined dyslipidemia
Brief summary
This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.
Detailed description
Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.
Interventions
DRUGPitavastatin
Pitavastatin 4 mg once daily
Sponsors
Kowa Research Europe
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777) * Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin. * Patients who have been following a fat and cholesterol restrictive diet.
Exclusion criteria
* Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study. * Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study. * Abnormal pancreatic, liver, or renal function * Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level * Significant heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Baseline to 52 Weeks | Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Cholesterol | Baseline to 52 weeks | Mean percent change from baseline in total cholesterol |
Countries
Denmark, Finland, Germany, India, Israel, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg QD Pitavastatin 4 mg once daily | 1,353 |
| Total | 1,353 |
Baseline characteristics
| Characteristic | Pitavastatin 4 mg QD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 412 Participants |
| Age, Categorical Between 18 and 65 years | 941 Participants |
| Age Continuous | 58.6 years STANDARD_DEVIATION 9.08 |
| Sex: Female, Male Female | 778 Participants |
| Sex: Female, Male Male | 575 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 293 / 1,353 |
| serious Total, serious adverse events | 49 / 1,353 |
Outcome results
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline to 52 Weeks
Population: Patients who had an observation at Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg QD | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | -42.89 percent change | Standard Deviation 16.001 |
Secondary
Change From Baseline in Total Cholesterol
Mean percent change from baseline in total cholesterol
Time frame: Baseline to 52 weeks
Population: Patients who had an observation at Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg QD | Change From Baseline in Total Cholesterol | -29.59 percent change | Standard Deviation 12.549 |