Mixed Dyslipidemia, Primary Dyslipidemia
Conditions
Brief summary
Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.
Interventions
DRUGpitavastatin
pitavastatin 4 mg once daily (QD)
DRUGpravastatin
Pravastatin 40 mg once daily (QD)
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent * Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL
Exclusion criteria
* Homozygous familial hypercholesterolemia * Any conditions which may cause secondary dyslipidemia * Uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | Baseline and 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg Once a Day (QD) | 164 |
| Pravastatin 40 mg Once a Day (QD) | 164 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | LDL-C elevation exceeding 250 mg/dL | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Persistent ALT or AST elevation | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Subject non-compliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Pravastatin 40 mg Once a Day (QD) | Pitavastatin 4 mg Once a Day (QD) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 42 Participants | 79 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 122 Participants | 249 Participants |
| Age Continuous | 57.0 years STANDARD_DEVIATION 10.23 | 58.8 years STANDARD_DEVIATION 8.93 | 57.9 years STANDARD_DEVIATION 9.63 |
| Region of Enrollment United States | 164 participants | 164 participants | 328 participants |
| Sex: Female, Male Female | 79 Participants | 83 Participants | 162 Participants |
| Sex: Female, Male Male | 85 Participants | 81 Participants | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 164 | 14 / 164 |
| serious Total, serious adverse events | 2 / 164 | 1 / 164 |
Outcome results
Primary
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12
Time frame: Baseline and 12 weeks
Population: All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg Once Daily (QD) | Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | -34.8 percent | Standard Error 1.2 |
| Pravastatin 40 mg Once Daily (QD) | Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 | -22.7 percent | Standard Error 1.22 |