HyperlipidemiaPhase 3NCT01386853
Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
A Phase 3 study testing Pitavastatin and Atorvastatin in people with Hyperlipidemia, run by Tai Tien Pharmaceuticals Co., Ltd. at 6 sites in Taiwan.
Trial summary
This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Pitavastatin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesTaiwan
- Study dates
- Jul 2011to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 20 years old and < 75 years old.
- Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
- Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
- Patient with at least one of the following description (NCEP ATP III guideline).
- Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
Who cannot join
- Patient who has participated in other investigational studies within 3 months.
- Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
- Patient is taking any medication or food that is prohibited by the study.
- Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
- Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
- Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
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- Patient with TG > 400 mg/dL.
- Excessive obesity defined as BMI above 35 kg/m2.
- Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
- Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio > 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
- Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
- Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
- Patient with CK level > 5 × ULRR at any time point between Visit 1 and Visit 2.
- Patient with poorly controlled diabetes mellitus (HbA1c > 9.0%) or patient with severe hypertension (> 180 mmHg for systolic or > 120 mmHg in diastolic blood pressure).
- Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
- Patient has significant alcohol consumption (> 65 mL pure alcohol) within 48 hours before Visit 2.
- Any major surgery within 3 months prior to Visit 2.
- Female patient who is lactating, being pregnant or plans to become pregnant.
- Patient with conditions judged by the investigator as unsuitable for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Changhua Christian Hospital
Chang-hua
Chien-Hsun Hsia, M.D.
Lee-Shin Lin, M.D.
National Cheng Kung University Hospital
Tainan
Ping-Yen Liu, M.D. Ph.D.
Po-Sheng Chen, M.D.
Chang Gung Memorial Hospital-LinKou
Taipei
Ming-Shien Wen, M.D. Ph.D.
Kuo-Chun Hung, M.D.
National Taiwan University Hospital
Taipei
Kuo-Liong Chien, M.D. Ph.D.
Chia-Lun Chao, M.D.
Taipei Veterans General Hospital
Taipei
Tao-Cheng Wu, M.D. Ph.D.
Chin-Chou Huang, M.D.
Tri-Service General Hospital
Taipei
About this study
Official title: A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.
- Conditions
- Hyperlipidemia
- Being tested
- Pitavastatin, Atorvastatin
- Keywords
- Hyperlipidemia, Pitavastatin, Atorvastatin
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called Livalo
2 mg QD
AtorvastatinDrug
Also called Lipitor
10 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin | Experimental | Not described Receives: Drug: Pitavastatin |
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of LDL-C
Measured: Baseline to 12 weeks
Secondary outcomes (1)
The proportion of patients achieving LDL-C < 100 mg/dL; the changes of HDL-C, TG, non-HDL-C, Apo A1 and Apo B, fasting plasma glucose, fasting insulin level, insulin resistance by the HOMA-IR, HbA1c, free fatty acid, and ADMA
Measured: Baseline to 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tai Tien Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaw-Wen Chen, M.D. Ph.D., Principal investigator, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386853
- Sponsor's protocol ID
- TATPITA20101005
- Status last verified
- Jun 2011
- First submitted
- 29 Jun 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin LY, Huang CC, Chen JS, Wu TC, Leu HB, Huang PH, Chang TT, Lin SJ, Chen JW. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study. Cardiovasc Diabetol. 2014 Jul 16;13:111. doi: 10.1186/s12933-014-0111-1.
PubMed 25027585Liu PY, Lin LY, Lin HJ, Hsia CH, Hung YR, Yeh HI, Wu TC, Chen JY, Chien KL, Chen JW. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013.
PubMed 24098467
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT01386853
- Acronym / sponsor ID
- TATPITA20101005
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, Pitavastatin, Atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tai Tien Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin | Experimental | Drug: Pitavastatin |
| Atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥ 20 years old and < 75 years old.
- Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
- Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
- Patient with at least one of the following description (NCEP ATP III guideline).
- Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.
Key exclusion criteria (19 listed)
- Patient who has participated in other investigational studies within 3 months.
- Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
- Patient is taking any medication or food that is prohibited by the study.
- Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
- Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
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 |
|---|---|---|
| PitavastatinAlso: Livalo2 mg QD | Drug | Pitavastatin |
| AtorvastatinAlso: Lipitor10 mg QD | Drug | Atorvastatin |
Primary outcome
The change of LDL-C
Time frame: Baseline to 12 weeks
1 secondary outcome
The proportion of patients achieving LDL-C < 100 mg/dL; the changes of HDL-C, TG, non-HDL-C, Apo A1 and Apo B, fasting plasma glucose, fasting insulin level, insulin resistance by the HOMA-IR, HbA1c, free fatty acid, and ADMA
Time frame: Baseline to 4 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 25027585Lin LY, Huang CC, Chen JS, Wu TC, Leu HB, Huang PH, Chang TT, Lin SJ, Chen JW. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study. Cardiovasc Diabetol. 2014 Jul 16;13:111. doi: 10.1186/s12933-014-0111-1.
- Derived from this study: PubMed 24098467Liu PY, Lin LY, Lin HJ, Hsia CH, Hung YR, Yeh HI, Wu TC, Chen JY, Chien KL, Chen JW. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013.
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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.
Jaw-Wen Chen, M.D. Ph.D. principal investigator
Taipei Veterans General Hospital, Taipei, Taiwan
6 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 Pitavastatin and Atorvastatin in people with Hyperlipidemia, run by Tai Tien Pharmaceuticals Co., Ltd. at 6 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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Chao (+886-27423012, jasmine@tanabe.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of LDL-C (time frame: Baseline to 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 NCT01386853, which also lists 2 linked publications.
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 1 Jul 2011.