HypercholesterolemiaPhase 4PITCHNCT01166633
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
A Phase 4 study testing pitavastatin and atorvastatin in people with Hypercholesterolemia, run by JW Pharmaceutical.
Trial summary
Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- pitavastatin and atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Feb 2011
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 25 and 75
- Patients who signed informed consent forms of their own volition;
- Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
- Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal
Who cannot join
- Patients with uncompensated liver cirrhosis.
- Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
- Patients who had taken antiviral drugs for viral hepatitis.
- Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
- Patients whose triglyceride(TG) levels were 400mg/dL or higher.
- Patients with uncontrolled hypertension (DBP≧100mmHg)
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- Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
- Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
- Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
- Female patients who were nursing or being pregnant or were planning on becoming pregnant.
- Patients judged to be unsuitable by investigators.
About this study
Official title: A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage
Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.
- Conditions
- Hypercholesterolemia
- Being tested
- pitavastatin, atorvastatin
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pitavastatinDrug
Also called LIVALO
pitavastatin 2mg per daily
atorvastatinDrug
Also called LIPITOR
atorvastatin 10mg per daily
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 2 mg | Experimental | Not described Receives: Drug: pitavastatin |
| Atorvastatin 10mg | Active comparator | Not described Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
Measured: 12 weeks
Secondary outcomes (4)
1.Changes in ALT after treatment
Measured: 12 weeks
2.Changes in AST after treatment
Measured: 12 weeks
3.Changes in LDL-C, TC, TG and HDL-C after treatment
Measured: 12 weeks
4.Changes in fat in liver after treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoo-Rok Han, Principal investigator, Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166633
- Sponsor's protocol ID
- CWP-PTV-707
- Acronym
- PITCH
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2010
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage
- ClinicalTrials.gov ID
- NCT01166633
- Acronym / sponsor ID
- PITCH / CWP-PTV-707
- Conditions
- Hypercholesterolemia
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jul 2010 (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.
Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 2 mg | Experimental | Drug: pitavastatin |
| Atorvastatin 10mg | Active comparator | Drug: atorvastatin |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 25 and 75
- Patients who signed informed consent forms of their own volition;
- Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
- Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal
Key exclusion criteria (11 listed)
- Patients with uncompensated liver cirrhosis.
- Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
- Patients who had taken antiviral drugs for viral hepatitis.
- Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
- Patients whose triglyceride(TG) levels were 400mg/dL or higher.
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: LIVALOpitavastatin 2mg per daily | Drug | Pitavastatin 2 mg |
| atorvastatinAlso: LIPITORatorvastatin 10mg per daily | Drug | Atorvastatin 10mg |
Primary outcome
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
Time frame: 12 weeks
4 secondary outcomes
1.Changes in ALT after treatment
Time frame: 12 weeks
2.Changes in AST after treatment
Time frame: 12 weeks
3.Changes in LDL-C, TC, TG and HDL-C after treatment
Time frame: 12 weeks
4.Changes in fat in liver after treatment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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Primary Prevention of Atherosclerotic Cardiovascular Disease
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
Kyoo-Rok Han principal investigator
Kangdong Sacred Heart Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pitavastatin and atorvastatin in people with Hypercholesterolemia, run by JW Pharmaceutical.
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 4 inclusion and 11 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.