Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

NCT ID: NCT01710007

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1PC002

2 mg 1PC002 once daily for 12 weeks.

Group Type: EXPERIMENTAL

1PC002

Intervention Type: 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.

Lipitor

10 mg atorvastatin once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Lipitor

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pitavastatin; Atorvastatin

Eligibility Criteria

Inclusion Criteria

1. Females or males aged between 20 and 80 years.

2. 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

3. Subjects who is willing and able to provide ICF.

Exclusion Criteria

1. Females who are pregnant, breast-feeding or intent to be pregnant during study period, or those of childbearing potential not using effective contraception.

2. Subject with documented homozygous familial hypercholesterolemia.

3. Subject with documented HIV.

4. Subject with documented hypothyroidism and inadequate treatment judged by investigator.

5. Subjects with unstable cardiovascular disease (CVD) prior to randomization.

6. Subjects with hepatic or biliary disorders, such as acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice.

7. Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

8. 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%

9. Subject with the following past histories:

• hypersensitivity to statins or any other ingredients of study drugs
• resistant to statins treatment

10. Use of any lipid-lowering agents within 4 weeks prior to the initiation of study treatment.

11. Use of any investigational product within 4 weeks prior to screening.

12. 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orient Europharma Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Orient Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chiau-Suong Liau

Role: PRINCIPAL_INVESTIGATOR

Buddhist Taipei TzuChi General Hospital

Ming-Shien Wen

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation- LinKuo Branch

Wen-Pin Huang

Role: PRINCIPAL_INVESTIGATOR

Cheng-Hsin General Hospital

Dee Pei

Role: PRINCIPAL_INVESTIGATOR

Cardinal Tien Hospital

Wei-Shiang Lin

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Huey-Herng Sheu

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Chen-Huan Chen

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Ju-Chi Liu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Buddhist Taipei TzuChi General Hospital

New Taipei City, , Taiwan

Cardinal Tien Hospital

New Taipei City, , Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Cheng Hsin General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation- LinKuo Branch

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

QCR10022

Identifier Type: -

Identifier Source: org_study_id