Phase 3
Completed N=178
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
Source: ClinicalTrials.gov NCT00344175 ↗Enrolled (actual)
178
Serious AEs
6.2%
Results posted
Jan 2010
Primary outcomePrimary: Number of Patients Attaining NCEP LDL-C Target at Week 16 — 98; 45 particpants
Summary
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Attaining NCEP LDL-C Target at Week 16 |
98; 45 | — |
| PRIMARY Number of Patients Attaining NCEP LDL-C Target at Week 44 |
94; 42 | — |
| SECONDARY Percent Change From Baseline in LDL-C |
-41.81; -41.37 | — |
Eligibility Criteria
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- Withdrawn or terminated from NK-104-304 (00309738)
Data sourced from ClinicalTrials.gov (NCT00344175). 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. Informational only — not medical advice.