HypercholesterolemiaPhase 3NCT00309738
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 35 sites in 4 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease. 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
- 355 participants
- Where
- 35 sitesin 4 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 of age)
- At least two cardiovascular disease risk factors
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Who cannot join
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
- Abnormal pancreatic, liver or renal function
- Abnormal serum creatine kinase (CK) above the pre-specified level
Trial locations and contacts
35 sites in 4 countries.
35 sites in 4 countries
Sweden11 sites
Angelholms Sjukhus, Medicinkliniken
Angelhom
Sahlgrenska University Hospital, Intermedicin
Gothenburg
Hjartmottagningen
Helsingborg
Lakarcentrum Nyponet
Karineholm
Medicinkliniken
Ludvika
Hjartmottagningen
Malmö
Huslakaren i Sandviken
Sandviken
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken
Hjart & Karlcenter
Södertälje
Karolinska Universitetssjukhuset
Stockholm
Hjarthuset AB
Varberg
Spain10 sites
Hospital Universitario de Bellvitge
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Fundacion Jimenez Diaz
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Ramon y Cajal
Madrid
Hospital Clinico S. Juan de Alicante
San Juan, Alicante
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Hospital de Sagunto
Valencia
Hospital Clinic i Provincial
Villaroel, Barcelona
Netherlands8 sites
Middellaan 5
Breda
Bomanshof 8
Eindhoven
Damsterdiep 9
Groningen
Doezastraat 1
Leiden
Kamerlingh Onnesstraat 16-18
Nijmegen
Mathenesserlaan 247
Rotterdam
Reigerstraat 30
Velp
Parkdreef 142
Zoetermeer
Denmark6 sites
CCBR A/S
Aalborg
CCBR A/S
Ballerup Municipality
Y Forskning, Bispebjerg Hospital
Copenhagen NV
Frederiks Hospital, Kardiologisk
Frederiksberg
Kolesterollaboratoriet
Hellerup
CCBR A/S
Vejle
About this study
Official title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Being tested
- pitavastatin, simvastatin
- Keywords
- Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin
- 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
simvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily Receives: Drug: pitavastatin |
| Simvastatin 40 mg QD | Active comparator | Simvastatin 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 LDL-C
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Measured: 12 weeks
Secondary outcomes (1)
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 355 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
- NCT00309738
- Sponsor's protocol ID
- NK-104-304
- Status last verified
- Mar 2010
- First submitted
- 8 Dec 2005
- Last updated
- 16 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.
PubMed 21874538
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 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 and 2 or More Risk Factors for Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00309738
- Acronym / sponsor ID
- NK-104-304
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Keywords
- Kowa, KRE, Hypercholesterolemia, combined dyslipidemia, dyslipidemia, pitavastatin, NK-104, simvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 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 18 Jan 2010
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 in patients with risk factors for heart disease.
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 4 mg QD | Experimental | Drug: pitavastatinPitavastatin 4 mg once daily |
| Simvastatin 40 mg QD | Active comparator | Drug: simvastatinSimvastatin 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 (4 listed)
- Males and females (18-75 years of age)
- At least two cardiovascular disease risk factors
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Key exclusion criteria (5 listed)
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
- Abnormal pancreatic, liver or renal function
- Abnormal serum creatine kinase (CK) above the pre-specified level
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 |
|---|---|---|
| pitavastatin | Drug | Pitavastatin 4 mg QD |
| simvastatin | Drug | Simvastatin 40 mg QD |
Primary outcome
Percent Change From Baseline in LDL-C
Time frame: 12 weeks
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
1 secondary outcome
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21874538Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.
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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
35 sites in 4 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 35 sites in 4 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 4 inclusion and 5 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 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Sweden, Spain, Netherlands, Denmark. 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 18 Jan 2010). 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 LDL-C (time frame: 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 NCT00309738, 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 16 Mar 2010.