HypercholesterolemiaPhase 4ProPitNCT00640276
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
A Phase 4 study testing pitavastatin and Lifestyle Modification in people with Hypercholesterolemia and Metabolic Syndrome, run by JW Pharmaceutical at 2 sites in South Korea.
Trial summary
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Metabolic Syndrome
- What is being tested?
- pitavastatin and Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2008to Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75
- Patients with LDL ≥ 100mg/dL
- Patients with metabolic syndrome
- IFG: Fasting glucose ≥ 100mg/dL
- Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm
- 1 or more of the following
Show all 9Show fewer
- Triglyceride ≥ 150mg/dL
- HDL-C: men < 40mg/dL, women < 50mg/dL
- Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment
Who cannot join
- uncontrolled hypertension (DBP ≥ 95mmHg)
- taking diabetic drugs or with HbA1c > 8%
- LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
- coronary heart disease or other diseases caused by artherosclerosis
- malignancy within 6 months
- Serum creatinine ≥ 2.0mg/dL
Show all 9Show fewer
- ALT or AST ≥ ULN*2.5
- CPK ≥ ULN*2
- hypothyroidism
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, 463-707
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, 471-701
About this study
Official title: A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.
- Conditions
- Hypercholesterolemia, Metabolic Syndrome
- Being tested
- pitavastatin, Lifestyle Modification
- Keywords
- pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pitavastatinDrug
Also called Livaro
Pitavastatin 2mg daily once
Lifestyle ModificationBehavioural
conducting mainly exercises and diet
| Study group | Role | What they receive |
|---|---|---|
| T | Active comparator | Lifestyle modification + active drug(Pitavastatin) Receives: Drug: pitavastatin |
| C | Other | Lifestyle Modification Receives: Behavioral: Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change of metabolic syndrome risk component
Measured: 48week
Secondary outcomes (3)
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin
Measured: 48week
Changes of abdominal visceral fat
Measured: 48week
Changes of insulin resistance : OGTT(75g), HOMA
Measured: 48week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2011
- Study completionJun 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang Beom Lee, Study chair, Hanyang Univ. Guri HospitalHak Chul Jang, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640276
- Sponsor's protocol ID
- CWP_PTV_706
- Acronym
- ProPit
- Status last verified
- Mar 2012
- First submitted
- 18 Mar 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00640276
- Acronym / sponsor ID
- ProPit / CWP_PTV_706
- Conditions
- Hypercholesterolemia, Metabolic Syndrome
- Keywords
- pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Mar 2008 (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.
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Active comparator | Drug: pitavastatinLifestyle modification + active drug(Pitavastatin) |
| C | Other | Behavioral: Lifestyle ModificationLifestyle Modification |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged between 18 and 75
- Patients with LDL ≥ 100mg/dL
- Patients with metabolic syndrome
Key exclusion criteria (9 listed)
- uncontrolled hypertension (DBP ≥ 95mmHg)
- taking diabetic drugs or with HbA1c > 8%
- LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
- coronary heart disease or other diseases caused by artherosclerosis
- malignancy within 6 months
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: LivaroPitavastatin 2mg daily once | Drug | T |
| Lifestyle Modificationconducting mainly exercises and diet | Behavioural | C |
Primary outcome
A change of metabolic syndrome risk component
Time frame: 48week
3 secondary outcomes
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin
Time frame: 48week
Changes of abdominal visceral fat
Time frame: 48week
Changes of insulin resistance : OGTT(75g), HOMA
Time frame: 48week
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 30 Mar 2012.
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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.
Chang Beom Lee study chair
Hanyang Univ. Guri Hospital
Hak Chul Jang study chair
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pitavastatin and Lifestyle Modification in people with Hypercholesterolemia and Metabolic Syndrome, run by JW Pharmaceutical at 2 sites in South Korea.
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 9 inclusion and 9 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 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?
A change of metabolic syndrome risk component (time frame: 48week). 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 30 Mar 2012.