HypercholesterolemiaPhase 3NCT00344175
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
A Phase 3 study testing pitavastatin and simvastatin in people with Hypercholesterolemia and Dyslipidemia, run by Kowa Research Europe at 28 sites in 4 countries.
Trial summary
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease
- What is being tested?
- pitavastatin and simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 28 sitesin 4 countries
- Study dates
- Jun 2006to Aug 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed NK-104-304 (NCT 00309738)
- Hypercholesterolemia or combined dyslipidemia
- 2 or more risk factors for coronary heart disease (CHD)
Who cannot join
- Withdrawn or terminated from NK-104-304 (00309738)
Trial locations and contacts
28 sites in 4 countries.
28 sites in 4 countries
Sweden10 sites
Angelholms Sjukhus, Medicinkliniken
Angelhom
Sahlgrenska University Hospital, Intermedicin
Gothenburg
Hjartmottagningen
Helsingborg
Lakarcentrum Nyponet
Karineholm
Medicinkliniken
Ludvika
Huslakaren i Sandviken
Sandviken
Narsjukhuset Sandviken, Kardiologlab, Medicin
Sandviken
Hjart & Karlcenter
Södertälje
Karolinska Universitetssjukhuset
Stockholm
Hjarthuset AB
Varberg
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
Spain6 sites
Hospital Universitario Reina Sofia
Córdoba
Hospital Ramon y Cajal
Madrid, 28000
Fundacion Jimenez Diaz
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Clinico S. Juan de Alicante
San Juan, Alicante
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Denmark4 sites
Y Forskning, Bispebjerg Hospital
Copenhagen Nv
Frederiks Hospital, Kardiologisk
Frederiksberg
Kolesterollaboratoriet
Hellerup
CCBR A/S
Vejle
About this study
Official title: Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Read the detailed description
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
- Conditions
- Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease
- Being tested
- pitavastatin, simvastatin
- Keywords
- hypercholesterolemia, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Coronary Disease
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 | Experimental | Pitavastatin 4 mg once daily Receives: Drug: pitavastatin |
| Simvastatin 40mg/80mg | Active comparator | Simvastatin 40 mg or 80 mg once daily Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Attaining NCEP LDL-C Target at Week 16
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Measured: 16 weeks
Number of Patients Attaining NCEP LDL-C Target at Week 44
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
Measured: 44 Weeks
Secondary outcomes (1)
Percent Change From Baseline in LDL-C
Measured: Baseline to 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dragos Budinski, MD, Study director, Kowa Research Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344175
- Sponsor's protocol ID
- NK-104-309
- Status last verified
- Jan 2010
- First submitted
- 22 Jun 2006
- Last updated
- 2 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eriksson M, Budinski D, Hounslow N. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. Epub 2011 Aug 25.
PubMed 21874537
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00344175
- Acronym / sponsor ID
- NK-104-309
- Conditions
- Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease
- Keywords
- hypercholesterolemia, dyslipidemia, CHD, pitavastatin, simvastatin, 2 or more risk factors for coronary heart disease, combined dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 26 Jun 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.
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Detailed description
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
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 | Experimental | Drug: pitavastatinPitavastatin 4 mg once daily |
| Simvastatin 40mg/80mg | Active comparator | Drug: simvastatinSimvastatin 40 mg or 80 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed NK-104-304 (NCT 00309738)
- Hypercholesterolemia or combined dyslipidemia
- 2 or more risk factors for coronary heart disease (CHD)
Key exclusion criteria (1 listed)
- Withdrawn or terminated from NK-104-304 (00309738)
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 |
| simvastatin | Drug | Simvastatin 40mg/80mg |
Primary outcome
Number of Patients Attaining NCEP LDL-C Target at Week 16
Time frame: 16 weeks
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Number of Patients Attaining NCEP LDL-C Target at Week 44
Time frame: 44 Weeks
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
1 secondary outcome
Percent Change From Baseline in LDL-C
Time frame: Baseline to 44 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21874537Eriksson M, Budinski D, Hounslow N. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. 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, MD study director
Kowa Research Europe
28 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 28 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 3 inclusion and 1 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 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Sweden, Netherlands, Spain, 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?
Number of Patients Attaining NCEP LDL-C Target at Week 16 (time frame: 16 weeks). The study lists 2 primary outcomes in all. 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 NCT00344175, 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 2 Feb 2010.