Phase 4
N=328
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Primary Dyslipidemia · Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01256476 ↗Enrolled (actual)
328
Serious AEs
0.9%
Results posted
Apr 2012
Primary outcome: Primary: Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 — -34.8; -22.7 percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pitavastatin (Drug); pravastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 |
-34.8; -22.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01256476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.