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Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

1PC002

Lipitor

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring HMG-CoA reductase inhibitors

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

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
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1PC002

Lipitor

Arm Description

2 mg 1PC002 once daily for 12 weeks.

10 mg atorvastatin once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

LDL-C

Percent change from baseline in LDL-C level at Week 4

HDL-C

Percent change from baseline in HDL-C level at Week 4

Triglyceride

Percent change from baseline in TG level at Week 4

Full Information

NCT ID

NCT01710007

First Posted

October 16, 2012

Last Updated

August 26, 2022

Sponsor

Orient Pharma Co., Ltd.

Collaborators

Orient Europharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01710007

Brief Title

Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orient Pharma Co., Ltd.

Collaborators

Orient Europharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a prospective, active-controlled, double-blind, randomized, parallel, and multi-center study. To target 150 evaluable subjects, approximately 200 Taiwanese patients with primary hypercholesterolemia or combined dyslipidemia will be enrolled in this study. After providing the written inform consent, patients will undergo a complete physical examination, vital sign (brachial BP / HR), medical history, and lab assessment, including fasting serum LDL-C, TC, HDL-C, TG, and non-HDL. They should not take any hypolipidemic drugs for at least 4 weeks prior to initiation of study treatment. All eligible subjects will be randomized into 2 groups in a 1:1 ratio to receive either 2 mg 1PC002 or 10 mg atorvastatin once daily for 12 weeks. Study Group: 1PC002 1 cap. q.d. p.o. Control Group: Atorvastatin 1 cap. q.d. p.o. After entering the baseline visit, lipid profiles (including fasting serum LDL-C, TC, HDL-C, TG, non-HDL, Apo A1, Apo B and Apo B / Apo A1 ratio), hs-CRP, eGFR, spot urinary albumin / creatinine ratio (ACR) and central BP values will be obtained at baseline, Week 4 and Week 12 for evaluating the effectiveness of study drugs and for any possible changes in laboratory data. Non-HDL value will be calculated by subtracting HDL-C from TC. Moreover, serum Cystatin C, another biomarker of renal function, will also be assessed at baseline and Week 12. For monitoring the safety, biochemical and hematological assessment will be performed at baseline, Week 4 and 12. Additional liver function and CK test will be conducted at Week 8. The occurring AE(s) and SAE will be followed until resolution or the event is considered stable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

HMG-CoA reductase inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1PC002

Arm Type

Experimental

Arm Description

2 mg 1PC002 once daily for 12 weeks.

Arm Title

Lipitor

Arm Type

Active Comparator

Arm Description

10 mg atorvastatin once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

1PC002

Other Intervention Name(s)

Pitavastatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lipitor

Other Intervention Name(s)

Atorvastatin

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

LDL-C

Description

Percent change from baseline in LDL-C level at Week 4

Time Frame

week 4

Title

HDL-C

Description

Percent change from baseline in HDL-C level at Week 4

Time Frame

week 4

Title

Triglyceride

Description

Percent change from baseline in TG level at Week 4

Time Frame

week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 < 400 mg/dL Subjects who is willing and able to provide ICF. Exclusion Criteria: 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 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.

Overall Study Officials: