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Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01710007
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
Orient Pharma Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: 1PC002 Drug: Lipitor Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1PC002
2 mg 1PC002 once daily for 12 weeks.
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.
Other Name: Pitavastatin

Active Comparator: Lipitor
10 mg atorvastatin once daily for 12 weeks.
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.
Other Name: Atorvastatin




Primary Outcome Measures :
  1. LDL-C [ Time Frame: 12 weeks ]
    Percent change from baseline in LDL-C level at Week 12


Secondary Outcome Measures :
  1. total cholesterol [ Time Frame: 4 weeks and 12 weeks ]
    Percent change from baseline in total cholesterol (TC) at Week 4 and 12

  2. HDL-C [ Time Frame: 4 weeks and 12 weeks ]
    Percent change from baseline in HDL-C level at Week 4 and 12

  3. Triglyceride [ Time Frame: 4 weeks and 12 weeks ]
    Percent change from baseline in TG level at Week 4 and 12



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710007


Locations
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Taiwan
Buddhist Taipei TzuChi General Hospital
New Taipei City, Taiwan, 23142
Cardinal Tien Hospital
New Taipei City, Taiwan, 231
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Taichung Veterans General Hospital
Taichung City, Taiwan, 40705
Taipei Veterans General Hospital
Taipei City, Taiwan, 11217
Cheng Hsin General Hospital
Taipei City, Taiwan, 112
Tri-Service General Hospital
Taipei City, Taiwan, 114
Chang Gung Medical Foundation- LinKuo Branch
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Orient Pharma Co., Ltd.
Orient Europharma Co., Ltd.
Investigators
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Principal Investigator: 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

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Responsible Party: Orient Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01710007    
Other Study ID Numbers: QCR10022
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013
Keywords provided by Orient Pharma Co., Ltd.:
HMG-CoA reductase inhibitors
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors