Phase 3
Completed N=202
Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
Source: ClinicalTrials.gov NCT01710007 ↗Enrolled (actual)
202
Serious AEs
2.0%
Results posted
Jul 2023
Primary outcomePrimary: The Percentage Change From Baseline in LDL-C Level at Week 12. — -42.89; -37.43 Percent change from baseline
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its active compound, pitavastatin has recently been approved by US FDA for indications of primary hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of 1PC002 administered for 12 weeks is non-inferior to atorvastatin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage Change From Baseline in LDL-C Level at Week 12. |
-42.89; -37.43 | — |
| SECONDARY LDL-C |
-39.01; -40.07 | — |
| SECONDARY HDL-C |
0.06; -1.64 | — |
| SECONDARY Triglyceride |
-18.75; -19.5 | — |
Eligibility Criteria
Inclusion Criteria
- Females or males aged between 20 and 80 years.
- Subjects who meet All of the following diagnosis at screening visit:
- Primary hypercholesterolemia or combined dyslipidemia
- TC ≥ 220 mg/dL or LDL-C ≥ 130 mg/dL
- TG 5 x upper limit of normal (ULN)
- ALT or AST of > 3 x ULN
- serum creatinine ≥ 1.5 mg/dL
- HbA1c > 8.0%
- Subject with the following past histories:
- hypersensitivity to statins or any other ingredients of study drugs
- resistant to statins treatment
- Use of any lipid-lowering agents within 4 weeks prior to the initiation of study treatment.
- Use of any investigational product within 4 weeks prior to screening.
- Any unstable concomitant disease or clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study.
Data sourced from ClinicalTrials.gov (NCT01710007). 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.