HypercholesterolemiaPhase 3NCT01710007

Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia

A Phase 3 study testing 1PC002 and Lipitor in people with Hypercholesterolemia, run by Orient Pharma Co., Ltd. at 8 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: 1PC002 and Lipitor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 8 sitesTaiwan
Study dates: Nov 2011to Nov 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 18Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Taiwan8 sites

Buddhist Taipei TzuChi General Hospital
New Taipei City, 23142
Cardinal Tien Hospital
New Taipei City, 231
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, 11217
Cheng Hsin General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 114
Chang Gung Medical Foundation- LinKuo Branch
Taoyuan City, 333

Other trials in Taiwan

About this study

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

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.

Read the 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
Being tested: 1PC002, Lipitor
Keywords: HMG-CoA reductase inhibitors
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1PC002Drug
Also called Pitavastatin
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.
LipitorDrug
Also called Atorvastatin
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.

Study groups in NCT01710007
Study group	Role	What they receive
1PC002	Experimental	2 mg 1PC002 once daily for 12 weeks. Receives: Drug: 1PC002
Lipitor	Active comparator	10 mg atorvastatin once daily for 12 weeks. Receives: Drug: Lipitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (3)

LDL-C
Percent change from baseline in LDL-C level at Week 4
Measured: week 4
HDL-C
Percent change from baseline in HDL-C level at Week 4
Measured: week 4
Triglyceride
Percent change from baseline in TG level at Week 4
Measured: week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Nov 2012

First posted18 Oct 2012 (estimated)
Study startNov 2011
Primary completionSep 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710007
Sponsor's protocol ID: QCR10022
Status last verified: Aug 2022
First submitted: 16 Oct 2012
Last updated: 17 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01710007
Acronym / sponsor ID: QCR10022
Conditions: Hypercholesterolemia
Keywords: HMG-CoA reductase inhibitors
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Orient Pharma Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Orient Europharma Co., Ltd.
Study start: Nov 2011
Primary completion: Sep 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 18 Oct 2012 (estimated)
Results: Posted 17 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Group: 1PC002 1 cap. q.d. p.o.
Control Group: Atorvastatin 1 cap. q.d. p.o.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1PC002	Experimental	Drug: 1PC0022 mg 1PC002 once daily for 12 weeks.
Lipitor	Active comparator	Drug: Lipitor10 mg atorvastatin once daily for 12 weeks.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Females or males aged between 20 and 80 years.
Subjects who meet All of the following diagnosis at screening visit:
Subjects who is willing and able to provide ICF.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1PC002Also: PitavastatinSubjects 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	1PC002
LipitorAlso: AtorvastatinSubjects 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

Primary outcome

The Percentage Change From Baseline in LDL-C Level at Week 12.
Time frame: 12 weeks
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.

3 secondary outcomes

LDL-C
Time frame: week 4
HDL-C
Time frame: week 4
Triglyceride
Time frame: week 4

Results and safety

Results posted to the registry on 17 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1PC002	103	87
Lipitor	99	81

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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	Lipitor n = 94	1PC002 n = 100
Value	-42.89 (12.80)	-37.43 (17.97)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12-16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1PC002	3 of 103 (2.9%)	58 of 103 (56.3%)	Not reported
Lipitor	1 of 99 (1%)	55 of 99 (55.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chiau-Suong Liau principal investigator

Buddhist Taipei TzuChi General Hospital

Ming-Shien Wen principal investigator

Chang Gung Medical Foundation- LinKuo Branch

Wen-Pin Huang principal investigator

Cheng-Hsin General Hospital

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 1PC002 and Lipitor in people with Hypercholesterolemia, run by Orient Pharma Co., Ltd. at 8 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage Change From Baseline in LDL-C Level at Week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710007.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.