HypercholesterolemiaPhase 3NCT00330876
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
A Phase 3 study testing Pitavastatin in people with Hypercholesterolemia and Dyslipidemias, run by Kowa Research Europe at 59 sites in 5 countries.
Trial summary
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemias
- What is being tested?
- Pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 59 sitesin 5 countries
- Study dates
- Jun 2006to Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
Who cannot join
- Failed to complete study NK-104-306(NCT00257686)
Trial locations and contacts
59 sites in 5 countries.
59 sites in 5 countries
United Kingdom20 sites
Oldfield Surgery
Bath
St James's Surgery
Bath
The Pulteney Practice
Bath
Birmingham Clinical Research Centre
Birmingham
Stonehill Medical Center
Bolton
Chorley Clinical Research Centre
Chorley
Saltash Health Center
Cornwall
Gomersal Lane Surgery
Dronfield
Townhead Research
Irvine
Crosby Clinical Research Centre
Liverpool
The Symons Medical Center
Maidenhead
Manchester Clinical Research Centre
Manchester
Greenwood Medical Center
Nottingham
Reading Clinical Research Centre
Reading
Elm Lane Surgery
Sheffield
Brook Lane Surgery
Southampton
Bradford Road Medical Center
Wiltshire
Rowden Medical Partnership
Wiltshire
The Porch Surgery
Wiltshire
The Burns Medical Practice
Yorkshire
Germany17 sites
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden/Taunus
Praxis Dr. Boenninghoff
Beckum
Klinische Forschung Berlin Mitte
Berlin
GWT-TUK GmbH, Zentrum fur Klinische Studien
Dresden
Gemeinschaftspraxis Dr. Krause, Th. Menke
Goch
Klinische Forschung Hamburg
Hamburg
Innere Medizin I/Medizinische Klinik
Heidelberg
Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl
Lampertheim
ZET-Studien GmbH Leipzig
Leipzig
Internistische Gemeinschaftspraxis
Mainz
Praxis Dr. Wachter
Mannheim
Gemeinschaftspraxis Melcherstaette
Melcherstaette
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
Messkirch
Praxisgemeinschaft im Kleinen Biergrund
Offenbach/M
Gemeinschaftspraxis Drs. Mockesch
Weinheim
Intermed Institud Fur Klinische Forschung und Arzn
Wiesbaden
Gemeinschaftspraxis Dr. Emden, Frank Drewes
Worpswede
Netherlands10 sites
Andromed Breda
Breda
Andromed Noord
Groningen
Vasculair Onderzoek Centrum Hoorn
Hoorn
Andromed Leiden
Leiden
Andromed Nijmegen
Nijmegen
Andromed Rotterdam
Rotterdam
Albert Schweitzer Ziekenhuis
Sliedrecht
Rivierenland Tiel
Tiel
Andromed Oost
Velp
Andromed Zoetermeer
Zoetermeer
Israel9 sites
Department of Internal Medicine, Soroka Medical Center
Beersheva
Department of Internal Medicine A, Rambal Medical Center
Haifa
Department of Internal Medicine, Wolfson Medical Center
Holon
Center for Research, Hadassah University Hospital
Jerusalem Ein Kerem
Meir Hospital
Kfar Saba
Department of Medicine, Hadassah Medical Center
Mount Scopus Jerusalem
Department of Internal Medicine, Rivka Sieff Medical Center
Safed
Institute of Metabolic Diseases
Tel Aviv
Institute of Lipid & Atherosclerosis Research
Tel HaShomer
Denmark3 sites
Copenhagen University Hospital
Copenhagen
Medical Center
Copenhagen
CCBR A/S
Vejle
About this study
Official title: Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
Read the detailed description
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Being tested
- Pitavastatin
- Keywords
- pitavastatin, hypercholesterolemia, 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
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 2 mg QD | Experimental | Pitavastatin 2 mg once daily Receives: Drug: Pitavastatin |
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily Receives: Drug: Pitavastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Measured: Baseline to 60 weeks
Secondary outcomes (1)
Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol (TC)
Measured: Baseline to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dragos Budinski, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330876
- Sponsor's protocol ID
- NK-104-308EU
- Status last verified
- Mar 2010
- First submitted
- 26 May 2006
- Last updated
- 16 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Open-Label, Long-Term (> 1 Year) Extension Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT00330876
- Acronym / sponsor ID
- NK-104-308EU
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Keywords
- pitavastatin, hypercholesterolemia, combined dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 May 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 an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
Detailed description
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 2 mg QD | Experimental | Drug: PitavastatinPitavastatin 2 mg once daily |
| Pitavastatin 4 mg QD | Experimental | Drug: PitavastatinPitavastatin 4 mg once daily |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 65 years of age
- Primary hypercholesterolemia
- Combined dyslipidemia
- Completed study NK-104-306 (NCT00257686)
Key exclusion criteria (1 listed)
- Failed to complete study NK-104-306(NCT00257686)
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 2 mg QD, Pitavastatin 4 mg QD |
Primary outcome
Change From Baseline in LDL-C
Time frame: Baseline to 60 weeks
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
1 secondary outcome
Change From Baseline in Total Cholesterol
Time frame: Baseline to 60 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.
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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
Medical Director
59 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 in people with Hypercholesterolemia and Dyslipidemias, run by Kowa Research Europe at 59 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 4 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 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 59 sites in United Kingdom, Germany, Netherlands, Israel, 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?
Change From Baseline in LDL-C (time frame: Baseline to 60 weeks). 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 16 Mar 2010.