Hypercholesterolemia or Combined DyslipidemiaPhase 3NCT00257686
Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
A Phase 3 study testing Pitavastatin and Pravastatin in people with Hypercholesterolemia or Combined Dyslipidemia, run by Kowa Research Europe at 62 sites in 5 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypercholesterolemia or Combined Dyslipidemia
- What is being tested?
- Pitavastatin and Pravastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 962 participants
- Where
- 62 sitesin 5 countries
- Study dates
- Sep 2005to May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Males and postmenopausal females (aged 65 years and older
- Eligible, able to participate, have given informed consent
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
- Agree to be available
Who cannot join
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus (HbA1c >8%).
- Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
- Liver injury
Show all 29Show fewer
- Impaired renal function
- Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful
- Serum CK >5 x ULRR without clinical explanation
- Uncontrolled hypothyroidism defined as TSH >ULRR
- Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
- Major surgery, 3 months prior to Visit 1
- Significant CVD prior to randomization
- Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of > 100 beats per minute at rest.
- Left ventricular ejection fraction <0.25;
- History of symptomatic cerebrovascular disease
- Any other conditions at the discretion of the investigator
- Known HIV infection
- Poorly controlled or uncontrolled hypertension
- Prior or current known muscular or neuromuscular disease of any type;
- Neoplastic disease
- Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
- Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
- Current or recent use of supplements known to alter lipid metabolism
- History of hypersensitivity to other HMG-CoA reductase inhibitors;
- Concomitant medication not permitted
- Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
- Excessive obesity
- Any factor which makes regular clinic attendance in the morning impractical ---Signs of mental dysfunction or other factors likely to limit ability to cooperate with the study.
Trial locations and contacts
62 sites in 5 countries.
62 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
Germany18 sites
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden / Taunus
Praxis Dr. Boenninghoff
Beckum
Klinische Forschung Berlin Mitte
Berlin
GWT-TUK mbH, 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 Leipzing
Leipzig
Internistische Gemeinschaftspraxis
Mainz
Praxis Dr. Wachter
Mannheim
Gemeinschaftspraxis Melcherstaette
Melcherstaette
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
Messkirch
Praxisgemeinschaft im Kleinen Biergrund
Offenbach/M
Gemeinschaftspraxis Melcherstaette
Stuhr-Brinkum
Gemeinschaftspraxis Drs. Mockesch
Weinheim
Intermed Institud Fur Klinische Forschung und Arzn
Wiesbaden
Gemeinschaftspraxis Dr. Emden, Frank Drewes
Worpswede
Netherlands11 sites
Andromed Oost
ES Velp
Andromed Noord
Groningen
Vasculair Onderzoek Centrum Hoorn
Hoorn
Andromed Leiden
Leiden
Andromed Nijmegen
Rotterdam
Andromed Rotterdam
Rotterdam
Albert Schweitzer ziekenhuis
Sliedrecht
Andromed Breda
VL Breda
Rivierenland Tiel
WP Tiel
Andromed Zoetermeer
Zoetermeer
Albert Schweitzer ziekenhuis
Zwijndrecht
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
Institue of Lipid & Atherosclerosis Research
Tel HaShomer
Denmark4 sites
CCBR A/S
Aalborg
Copenhagen University Hospital
Copenhagen
Medical Center
Copenhagen
CCBR A/S
Vejle
About this study
Official title: Study Of Pitavastatin 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of pravastatin in elderly patients
Read the detailed description
Following a wash-out dietary lead-in period, patients will receive either Preavastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
- Being tested
- Pitavastatin, Pravastatin
- Keywords
- Kowa, Hypercholesterolemia, combined, dyslipidemia, elderly, pitavastatin, NK-104
- 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
PravastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 1 mg | Experimental | Pitavastatin 1 mg once daily Receives: Drug: Pitavastatin |
| Pravastatin 10 mg | Active comparator | Pravastatin 10 mg once daily Receives: Drug: Pravastatin |
| Pitavastatin 2 mg | Experimental | Pitavastatin 2 mg once daily Receives: Drug: Pitavastatin |
| Pravastatin 20 mg | Active comparator | Pravastatin 20 mg once daily Receives: Drug: Pravastatin |
| Pitavastatin 4 mg | Experimental | Pitavastatin 4 mg once daily Receives: Drug: Pitavastatin |
| Pravastatin 40 mg | Active comparator | Pravastatin 40 mg once daily Receives: Drug: Pravastatin |
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 cholesterol (LDL-C)
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Percent Change From Baseline in TC
Percent change from baseline in total cholesterol (TC)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionMay 2006
- Study completionMay 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 Hypercholesterolemia or Combined DyslipidemiaStudies 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
- 962 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
- NCT00257686
- Sponsor's protocol ID
- NK-104-306
- Status last verified
- Mar 2010
- First submitted
- 21 Nov 2005
- Last updated
- 16 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013 Feb;20(1):40-53. doi: 10.1177/2047487312451251. Epub 2012 Jun 7.
PubMed 22679249
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 1 Mg Vs. Pravastatin 10 Mg, Pitavastatin 2 Mg Vs. Pravastatin 20 Mg And Pitavastatin 4 Mg Vs. Pravastatin 40 Mg (Following Up-Titration) In Elderly Patients With Primary Hypercholesterolemia Or Combined Dyslipidemia
- ClinicalTrials.gov ID
- NCT00257686
- Acronym / sponsor ID
- NK-104-306
- Keywords
- Kowa, Hypercholesterolemia, combined, dyslipidemia, elderly, pitavastatin, NK-104
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 962 participants (actual)
- Lead sponsor
- Kowa Research EuropeIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 23 Nov 2005 (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 pravastatin in elderly patients
Detailed description
Following a wash-out dietary lead-in period, patients will receive either Preavastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 1 mg | Experimental | Drug: PitavastatinPitavastatin 1 mg once daily |
| Pravastatin 10 mg | Active comparator | Drug: PravastatinPravastatin 10 mg once daily |
| Pitavastatin 2 mg | Experimental | Drug: PitavastatinPitavastatin 2 mg once daily |
| Pravastatin 20 mg | Active comparator | Drug: PravastatinPravastatin 20 mg once daily |
| Pitavastatin 4 mg | Experimental | Drug: PitavastatinPitavastatin 4 mg once daily |
| Pravastatin 40 mg | Active comparator | Drug: PravastatinPravastatin 40 mg once daily |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Males and postmenopausal females (aged 65 years and older
- Eligible, able to participate, have given informed consent
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations between Week -4 and -1
Key exclusion criteria (29 listed)
- Homozygous familial hypercholesterolemia
- Conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus (HbA1c >8%).
- Any condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
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 1 mg, Pitavastatin 2 mg, Pitavastatin 4 mg |
| Pravastatin | Drug | Pravastatin 10 mg, Pravastatin 20 mg, Pravastatin 40 mg |
Primary outcome
Percent Change From Baseline in LDL-C
Time frame: Baseline to 12 weeks
Percent change from baseline in low density cholesterol (LDL-C)
1 secondary outcome
Percent Change From Baseline in TC
Time frame: Baseline to 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 22679249Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013 Feb;20(1):40-53. doi: 10.1177/2047487312451251. Epub 2012 Jun 7.
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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
Medical Director
62 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 Pravastatin in people with Hypercholesterolemia or Combined Dyslipidemia, run by Kowa Research Europe at 62 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 6 inclusion and 29 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 62 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?
Percent Change From Baseline in LDL-C (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 NCT00257686, 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.