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Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

NCT01710007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-07-17

Study results available
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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.

Conditions

Interventions

DRUG

1PC002

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.

DRUG

Lipitor

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.

Sponsors & Collaborators

  • Orient Europharma Co., Ltd.

    collaborator INDUSTRY

  • Orient Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chiau-Suong Liau · Buddhist Taipei TzuChi General Hospital

  • Ming-Shien Wen · Chang Gung Medical Foundation- LinKuo Branch

  • Wen-Pin Huang · Cheng-Hsin General Hospital

  • Dee Pei · Cardinal Tien Hospital

  • Wei-Shiang Lin · Tri-Service General Hospital

  • Huey-Herng Sheu · Taichung Veterans General Hospital

  • Chen-Huan Chen · Taipei Veterans General Hospital, Taiwan

  • Ju-Chi Liu · Taipei Medical University Shuang Ho Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710007 on ClinicalTrials.gov