Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

NCT01710007 | Completed Phase 3 Results

• 1 other identifier: QCR10022
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 8

Brief 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

Hypercholesterolemia

Keywords

HMG-CoA reductase inhibitors

Outcome Measures

Primary Outcomes (1)

• The Percentage Change From Baseline in LDL-C Level at Week 12.

  The study aimed to test that the efficacy of 1PC002 group was non-inferior to Atorvastatin group in percent change from baseline of LDL-C level at Week 12.

  12 weeks

Secondary Outcomes (3)

• LDL-C

  week 4

• HDL-C

  week 4

• Triglyceride

  week 4

Study Arms (2)

1PC002

EXPERIMENTAL

2 mg 1PC002 once daily for 12 weeks.

Drug: 1PC002

Lipitor

ACTIVE COMPARATOR

10 mg atorvastatin once daily for 12 weeks.

Drug: Lipitor

Interventions

1PC002 DRUG

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.

Also known as: Pitavastatin

1PC002

Lipitor DRUG

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.

Also known as: Atorvastatin

Lipitor

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 400 mg/dL
• Subjects who is willing and able to provide ICF.

You may not qualify if:

• Females who are pregnant, breast-feeding or intent to be pregnant during study period, or those of childbearing potential not using effective contraception.
• Subject with documented homozygous familial hypercholesterolemia.
• Subject with documented HIV.
• Subject with documented hypothyroidism and inadequate treatment judged by investigator.
• Subjects with unstable cardiovascular disease (CVD) prior to randomization.
• Subjects with hepatic or biliary disorders, such as acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice.
• Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
• Subjects with the following lab data at screening visit:
• serum creatine kinase (CK) \> 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

Sponsors & Collaborators

• Orient Pharma Co., Ltd.: lead
• Orient Europharma Co., Ltd.: collaborator

Study Sites (8)

Buddhist Taipei TzuChi General Hospital

New Taipei City, 23142, Taiwan

Location

Cardinal Tien Hospital

New Taipei City, 231, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation- LinKuo Branch

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Vivian Lu
• Organization: Orient Europharma Co., Ltd.

Vivian.Lu@oppharma.com

+886-2-2755-4881

Study Officials

• Chiau-Suong Liau

  Buddhist Taipei TzuChi General Hospital

  PRINCIPAL INVESTIGATOR

• Ming-Shien Wen

  Chang Gung Medical Foundation- LinKuo Branch

  PRINCIPAL INVESTIGATOR

• Wen-Pin Huang

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

• Dee Pei

  Cardinal Tien Hospital

  PRINCIPAL INVESTIGATOR

• Wei-Shiang Lin

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

• Huey-Herng Sheu

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Chen-Huan Chen

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Ju-Chi Liu

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Locations

TW (8)