Hypercholesterolemia With Type2DMPhase 4ESPRITNCT00889226
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
A Phase 4 study testing Pitavastatin and Atorvastatin in people with Hypercholesterolemia With Type2DM, run by JW Pharmaceutical.
Trial summary
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypercholesterolemia With Type2DM
- What is being tested?
- Pitavastatin and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jan 2010
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 25yrs~75yrs
- Fasting TG <400mg/dL, LDL-C ≥130mg/dL
- 3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
Who cannot join
- Type1 DM, Gestational diabetes
- Patient need to treat with Insulin
- Patient with operational treatment for severe diabetic complication
- Uncontrolled Hypothyroidism
- Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
- Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
Show all 11Show fewer
- Renal disorder (Serum creatinine ≥ 2.0mg/dL)
- Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
- Creatinine Kinase > 2.5 X UNL
- Gravida or lactation phase
- Administration of Atorvastatin, Rosuvastatin, Pitavastatin
About this study
Official title: A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Read the detailed description
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
- Conditions
- Hypercholesterolemia With Type2DM
- Being tested
- Pitavastatin, Atorvastatin
- Keywords
- pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Also called Livalo
Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks
AtorvastatinDrug
Also called Lipitor
Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin Group | Experimental | Not described Receives: Drug: Pitavastatin |
| Atorvastatin Group | 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 Patients Achieving LDL- C<100mg/dL
compare the proportion of patients achieving LDL- C<100mg/dL
Measured: After 16wk drug administration
Secondary outcomes (1)
The Change of LDL-C
The change of LDL-C between at 16-week and baseline
Measured: After 16wk drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionJan 2010
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 Hypercholesterolemia With Type2DMStudies 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ho Young Shon, MD, Principal investigator, Endocrinology, Kangnam Saint Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889226
- Sponsor's protocol ID
- CWP_PTV4_704
- Acronym
- ESPRIT
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2009
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. 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 Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00889226
- Acronym / sponsor ID
- ESPRIT / CWP_PTV4_704
- Conditions
- Hypercholesterolemia With Type2DM
- Keywords
- pitavastatin, PWV, ESPRIT, Pitavastatin and Atorvastatin, Adiponectin, fasting insulin, hs-CRP, baPWV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Detailed description
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin Group | Experimental | Drug: Pitavastatin |
| Atorvastatin Group | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 25yrs~75yrs
- Fasting TG <400mg/dL, LDL-C ≥130mg/dL
- 3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
Key exclusion criteria (11 listed)
- Type1 DM, Gestational diabetes
- Patient need to treat with Insulin
- Patient with operational treatment for severe diabetic complication
- Uncontrolled Hypothyroidism
- Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
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: LivaloDrug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks | Drug | Pitavastatin Group |
| AtorvastatinAlso: LipitorDrug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks | Drug | Atorvastatin Group |
Primary outcome
Proportion of Patients Achieving LDL- C<100mg/dL
Time frame: After 16wk drug administration
compare the proportion of patients achieving LDL- C<100mg/dL
1 secondary outcome
The Change of LDL-C
Time frame: After 16wk drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ho Young Shon, MD principal investigator
Endocrinology, Kangnam Saint Mary's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin and Atorvastatin in people with Hypercholesterolemia With Type2DM, 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 3 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 17 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2019). 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?
Proportion of Patients Achieving LDL- C<100mg/dL (time frame: After 16wk drug administration). 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 17 Sep 2019.