Dyslipidemias, Hypercholesterolemia
Conditions
Keywords
pitavastatin, hypercholesterolemia, combined dyslipidemia
Brief summary
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
Detailed description
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
Interventions
DRUGPitavastatin
Sponsors
Kowa Research Europe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 65 years of age * Primary hypercholesterolemia * Combined dyslipidemia * Completed study NK-104-306 (NCT00257686)
Exclusion criteria
* Failed to complete study NK-104-306(NCT00257686)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in LDL-C | Baseline to 60 weeks | percent change from baseline in low density lipoprotein-cholesterol (LDL-C) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Cholesterol | Baseline to 60 weeks | Percent change from baseline in total cholesterol (TC) |
Countries
Denmark, Germany, Israel, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety Population Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily | 539 |
| Total | 539 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 539 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 70.3 years STANDARD_DEVIATION 4.73 |
| Sex: Female, Male Female | 294 Participants |
| Sex: Female, Male Male | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 286 / — | 24 / — |
| serious Total, serious adverse events | 51 / 449 | 7 / 90 |
Outcome results
Primary
Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline to 60 weeks
Population: Subjects with measurement at Week 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 2 mg QD | Change From Baseline in LDL-C | -43.18 percent change | Standard Deviation 10.065 |
| Pitavastatin 4 mg QD | Change From Baseline in LDL-C | -44.26 percent change | Standard Deviation 10.764 |
Secondary
Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol (TC)
Time frame: Baseline to 60 weeks
Population: Subjects with a measurement at Week 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 2 mg QD | Change From Baseline in Total Cholesterol | -28.27 percent change | Standard Deviation 8.214 |
| Pitavastatin 4 mg QD | Change From Baseline in Total Cholesterol | -30.54 percent change | Standard Deviation 8.226 |