HypercholesterolemiaPhase 3NCT00309777
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
A Phase 3 study testing Pitavastatin and Simvastatin in people with Hypercholesterolemia and Dyslipidemia, run by Kowa Research Europe at 42 sites in 5 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemia
- What is being tested?
- Pitavastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 857 participants
- Where
- 42 sitesin 5 countries
- Study dates
- Sep 2005to Oct 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (18-75 years)
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Who cannot join
- Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
- Conditions which may cause secondary dyslipidemia.
- Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
- Abnormal serum creatine kinase (CK) above the pre-specified level
- Abnormal pancreatic, liver or renal function
- Significant heart disease
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
Russia12 sites
Kemerovo Cardiology Dispensary
Kemerovo
Central Clinical Hospital 1 of RZD
Moscow
City Clinical Hospital 23
Moscow
City Clinical Hospital 64
Moscow
Moscow City Clinical Hospital 68
Moscow
State Research Center for Preventive Medicine
Moscow
Novosibirsk Reg. Clinical Cardiology Dispensary
Novosibirsk
Central Medical Unit 122, St. Pb
Saint Petersburg
Clinical Hospital of Russian Academy of Sciences
Saint Petersburg
Consulting and Diagnostic Center 85
Saint Petersburg
Krestovsky Island Medical Institute
Saint Petersburg
Pokrovskaya City Hospital
Saint Petersburg
Italy10 sites
Dipartimento Di Medicina Clinica e Biotecnologia Applicata
Bologna
Centro di Ricerca Clinica
Chieti
Gerontologia e Geriatria - Universita degli Studi
Ferrara
Dipartimento di Medicina Interna DIMI
Genova
Universita di Modena e Reggio Emilia, Policlinico
Modena
Dipartimento di Medicina Clinica e Sperimentale
Naples
Medicina Clinica e delle Patologie Emergenti
Palermo
Dipartimento di Medicina Interna e Scienze Biomediche
Parma
U.O Malattie Metaboliche e Diabetologia
Treviglio
Azienda Ospedaliero-Universitaria
Trieste
United Kingdom10 sites
St Michael's Partnership
Bath
Avondale Surgery
Chesterfield
Knowle House Surgery
Plymouth
The Burngreave Surgery
Sheffield
St Helier Hospital
Surrey
Box Surgery
Wiltshire
Eastleigh Surgery
Wiltshire
Lovemead Group Practice
Wiltshire
St Chad's Surgery
Wiltshire
The Health Centre
Wiltshire
Finland5 sites
Geri-Med Oy
Helsinki
Kaisaniemen Laakariasema
Helsinki
Keravan Laakarikeskus
Helsinki
SOK-tyoterveyshuolto
Tampere
TYKS University Hospital
Turku
Norway5 sites
Volvat Medisinske Senter
Fredrikstad
Nyomen Legekontor
Kongsberg
Radhuset Spesialistsenter
Oslo
Rikshospitalet - University Hospital
Oslo
Skedsmo Medisinske Senter A.S.
Skedsmokorset
About this study
Official title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Being tested
- Pitavastatin, Simvastatin
- Keywords
- hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Pitavastatin once daily
SimvastatinDrug
Simvastatin once daily
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 2 mg | Experimental | Pitavastatin 2 mg once daily Receives: Drug: Pitavastatin |
| Simvastatin 20 mg | Active comparator | Simvastatin 20 mg once daily Receives: Drug: Simvastatin |
| Pitavastatin 4 mg | Experimental | Pitavastatin 4 mg once daily Receives: Drug: Pitavastatin |
| Simvastatin 40 mg | Active comparator | Simvastatn 40 mg once daily Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
Measured: Baseline to 12 weeks
Secondary outcomes (1)
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionOct 2006
- Study completionOct 2006
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dragos Budinski, Med Dr., Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309777
- Sponsor's protocol ID
- NK-104-302
- Other IDs
- EudraCT number 2005-001033-15
- Status last verified
- Jan 2010
- First submitted
- 11 Nov 2005
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009 Nov;25(11):2755-64. doi: 10.1185/03007990903290886.
PubMed 19785568
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT00309777
- Acronym / sponsor ID
- NK-104-302
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Keywords
- hypercholesterolemia, kowa, dyslipidemia, pitavastatin, NK-104, Primary Hypercholesterolemia or Combined Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 857 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Posted 16 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 2 mg | Experimental | Drug: PitavastatinPitavastatin 2 mg once daily |
| Simvastatin 20 mg | Active comparator | Drug: SimvastatinSimvastatin 20 mg once daily |
| Pitavastatin 4 mg | Experimental | Drug: PitavastatinPitavastatin 4 mg once daily |
| Simvastatin 40 mg | Active comparator | Drug: SimvastatinSimvastatn 40 mg once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females (18-75 years)
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Key exclusion criteria (6 listed)
- Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
- Conditions which may cause secondary dyslipidemia.
- Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
- Abnormal serum creatine kinase (CK) above the pre-specified level
- Abnormal pancreatic, liver or renal function
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 |
|---|---|---|
| PitavastatinPitavastatin once daily | Drug | Pitavastatin 2 mg, Pitavastatin 4 mg |
| SimvastatinSimvastatin once daily | Drug | Simvastatin 20 mg, Simvastatin 40 mg |
Primary outcome
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks
Time frame: Baseline to 12 weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks
1 secondary outcome
National Cholesterol Education Program (NCEP) LDL-C Target Attainment
Time frame: 12 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19785568Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009 Nov;25(11):2755-64. doi: 10.1185/03007990903290886.
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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.
Dragos Budinski, Med Dr. study director
Medical Director
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pitavastatin and Simvastatin in people with Hypercholesterolemia and Dyslipidemia, run by Kowa Research Europe at 42 sites in 5 countries.
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 6 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Russia, Italy, United Kingdom, Finland, Norway. 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 16 Dec 2009). 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?
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (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 NCT00309777, which also lists 1 linked publication.
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 12 Jan 2010.