CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 202 enrolled
Drug / intervention
1PC002 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01710007
NCT01710007Phase 3Completed
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A Prospective, Double-blind, Randomized, Parallel, Multiple-center Study to Compare the Efficacy and Safety of 1PC002 and Atorvastatin in Taiwanese Patients With Hypercholesterolemia

Orient Pharma Co., Ltd.·interventional·Posted Oct 18, 2012·Updated Jul 17, 2023

In Brief

A Phase 3 clinical trial evaluating 1PC002 and Lipitor for Hypercholesterolemia. Completed, enrolled 202 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesTaiwan
CollaboratorsOrient Europharma Co., Ltd.

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.7 years ago

Interventions

1PC002drug

Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.

Lipitordrug

Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.