HypercholesterolemiaPhase 3NCT00268697
Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia.
A Phase 3 study testing Lapaquistat acetate, Lapaquistat acetate and ezetimibe and Ezetimibe in people with Hypercholesterolemia, run by Takeda at 9 sites in 4 countries.
Trial summary
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lapaquistat acetate, Lapaquistat acetate and ezetimibe and Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,267 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Oct 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors but without type 1 or 2 diabetes.
- At Randomization, participants must fulfill the above criteria and also have a mean fasting low density lipoprotein cholesterol levels greater than or equal to 3.36 mmol/L and less than or equal to 5.6 mmol/L and mean triglyceride levels less than or equal to 4.52 mmol/L.
- Is willing and able to comply with the recommended, standardized diet.
Who cannot join
- Has active liver disease or jaundice.
- Has a history of cancer, other than basal cell carcinoma, that had been in remission for less than 5 years prior to the first dose of study drug.
- Has an endocrine disorder, such as Cushing Syndrome, hyperthyroidism, or inappropriately treated hypothyroidism affecting lipid metabolism.
- Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or the subject's verbal report.
- Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history and/or the subject's verbal report. .
- Has participated in any other clinical studies with lapaquistat acetate, was concurrently participating in another investigational study, had participated in an investigational study within the past 30 days or, for drugs with a long half-life, within a period of less than 5 times the drug's half-life.
Show all 18Show fewer
- Has a known hypersensitivity or history of intolerance to lapaquistat acetate or ezetimibe.
- Has a history or presence of clinically significant food allergy that would prevent adherence to the specialized diet.
- Has a known heterozygous or homozygous familial hypercholesterolemia or known Type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain and/or discontinuation of HMG-CoA reductase inhibitors due to myalgia at any time.
- Has uncontrolled hypertension despite medical treatment.
- Has inflammatory bowel or any other malabsorption syndrome or had had gastric bypass surgery or any other surgical procedure for weight loss.
- Has a history of drug abuse or a history of high alcohol intake within the previous 2 years.
- Has any other serious disease or condition at Visit 1 or Randomization that might reduce life expectancy, impaired successful management according to the protocol, or make the participant unsuitable to receive study drug.
- Has a history of coronary heart disease or coronary heart disease-risk factors comprised of:
- Diabetes mellitus type 1 or 2
- History or presence of myocardial infarction, angina pectoris, unstable angina, coronary angioplasty, coronary or peripheral arterial surgery (bypass graft), aortic aneurysm, transient ischemic attacks, or cerebrovascular accident;
- Multiple risk factors that confer a 10-year risk of coronary heart disease greater than 20% based on the Framingham risk score.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Russia5 sites
Study site
Moscow
Study site
Saint Petersburg
Study site
Saratov
Study site
Smolensk
Study site
Tyumen
About this study
Official title: A Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia
Read the detailed description
In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol plasma levels; however, in subjects with hypercholesterolemia, elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls (atherosclerosis) and subsequent coronary heart disease. Thus, it has been established that lowering the low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. Additional lipid risk factors for coronary heart disease include elevated triglyceride, very low-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels, and low levels of high-density lipoprotein cholesterol.
Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in Britain and much of Europe, the United States, Australia, and New Zealand, representing a serious public health concern.
Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (ie, statins) are the first-line monotherapies prescribed for the treatment of dyslipidemia, after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels. Statins reduce low-density lipoprotein cholesterol and triglycerides, increase high-density lipoprotein cholesterol, and improve endothelial function. Treatment with statins reduces the risk of a vascular event by about 30% in subjects with and without symptoms of arteriosclerosis; however, many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy. Consequently, the dosage of statins is often increased or an additional treatment is added; the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines.
Ezetimibe is a lipid-lowering compound that selectively inhibits intestinal absorption of cholesterol at the brush border of the small intestine, leading to a decrease in the delivery of intestinal cholesterol to the liver. Ezetimibe does not affect the absorption of triglycerides, fatty acids, bile acids, progesterone, ethinylestradiol, or fat-soluble vitamins A and D.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of lapaquistat acetate taken with ezetimibe in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 24 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Lapaquistat acetate, Lapaquistat acetate and ezetimibe, Ezetimibe
- Keywords
- Hyperlipidemia, Drug Therapy
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapaquistat acetateDrug
Also called TAK-475
Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 24 weeks.
Lapaquistat acetate and ezetimibeDrug
Also called TAK-475, Zetia
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
EzetimibeDrug
Also called Zetia
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lapaquistat Acetate 100 mg QD | Experimental | Not described Receives: Drug: Lapaquistat acetate |
| Lapaquistat Acetate 100 mg QD + Ezetimibe | Experimental | Not described Receives: Drug: Lapaquistat acetate and ezetimibe |
| Ezetimibe | Active comparator | Not described Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Secondary outcomes (19)
Change from Baseline in Triglycerides
Measured: Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in apolipoprotein A1
Measured: Week 24 or Final Visit
Change from Baseline in apolipoprotein B
Measured: Week 24 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Measured: Week 24 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Measured: Week 24 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)
Measured: Week 24 or Final Visit
Best corrected visual acuity
Measured: Week 24 or Final Visit
Adverse Events
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Clinical Laboratory Tests
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Vital Signs
Measured: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
12-lead Electrocardiogram
Measured: Weeks 12 and 24 or Final Visit
Physical Examination
Measured: Week 24 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 1,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268697
- Sponsor's protocol ID
- TAK-475/EC303
- Other IDs
- 2005-002315-25, U1111-1122-8322, 2005
- Status last verified
- May 2012
- First submitted
- 20 Dec 2005
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.
PubMed 21518985
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg and Lapaquistat Acetate 100 mg Administered in Combination With Ezetimibe 10 mg vs Ezetimibe 10 mg in Subjects With Primary Dyslipidemia
- ClinicalTrials.gov ID
- NCT00268697
- Acronym / sponsor ID
- TAK-475/EC303
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,267 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Not posted in the source record
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 the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia
Detailed description
In humans, cholesterol is acquired from dietary sources and is produced de novo in the liver, intestine, and various other tissues. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol plasma levels; however, in subjects with hypercholesterolemia, elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls (atherosclerosis) and subsequent coronary heart disease. Thus, it has been established that lowering the low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. Additional lipid risk factors for coronary heart disease include elevated triglyceride, very low-density lipoprotein cholesterol and low-density lipoprotein cholesterol levels, and low levels of high-density lipoprotein cholesterol.
Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in Britain and much of Europe, the United States, Australia, and New Zealand, representing a serious public health concern.
Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (ie, statins) are the first-line monotherapies prescribed for the treatment of dyslipidemia, after diet and therapeutic lifestyle changes alone fail to reduce low-density lipoprotein cholesterol to desired levels. Statins reduce low-density lipoprotein cholesterol and triglycerides, increase high-density lipoprotein cholesterol, and improve endothelial function. Treatment with statins reduces the risk of a vascular event by about 30% in subjects with and without symptoms of arteriosclerosis; however, many subjects fail to reach recommended levels of low-density lipoprotein cholesterol reduction after receiving low-dose statins as a monotherapy. Consequently, the dosage of statins is often increased or an additional treatment is added; the latter has become an important therapeutic option for achieving increasingly stringent lipid targets set forth by international therapeutic guidelines.
Ezetimibe is a lipid-lowering compound that selectively inhibits intestinal absorption of cholesterol at the brush border of the small intestine, leading to a decrease in the delivery of intestinal cholesterol to the liver. Ezetimibe does not affect the absorption of triglycerides, fatty acids, bile acids, progesterone, ethinylestradiol, or fat-soluble vitamins A and D.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of lapaquistat acetate taken with ezetimibe in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lapaquistat Acetate 100 mg QD | Experimental | Drug: Lapaquistat acetate |
| Lapaquistat Acetate 100 mg QD + Ezetimibe | Experimental | Drug: Lapaquistat acetate and ezetimibe |
| Ezetimibe | Active comparator | Drug: Ezetimibe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
- Has a documented history of dyslipidemia with or without cardiovascular risk factors but without type 1 or 2 diabetes.
- At Randomization, participants must fulfill the above criteria and also have a mean fasting low density lipoprotein cholesterol levels greater than or equal to 3.36 mmol/L and less than or equal to 5.6 mmol/L and mean triglyceride levels less than or equal to 4.52 mmol/L.
- Is willing and able to comply with the recommended, standardized diet.
Key exclusion criteria (18 listed)
- Has active liver disease or jaundice.
- Has a history of cancer, other than basal cell carcinoma, that had been in remission for less than 5 years prior to the first dose of study drug.
- Has an endocrine disorder, such as Cushing Syndrome, hyperthyroidism, or inappropriately treated hypothyroidism affecting lipid metabolism.
- Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or the subject's verbal report.
- Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history and/or the subject's verbal report. .
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 |
|---|---|---|
| Lapaquistat acetateAlso: TAK-475Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 24 weeks. | Drug | Lapaquistat Acetate 100 mg QD |
| Lapaquistat acetate and ezetimibeAlso: TAK-475, ZetiaLapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. | Drug | Lapaquistat Acetate 100 mg QD + Ezetimibe |
| EzetimibeAlso: ZetiaLapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. | Drug | Ezetimibe |
Primary outcome
Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
19 secondary outcomes
Change from Baseline in Triglycerides
Time frame: Week 24 or Final Visit
Change from Baseline in Total Cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in apolipoprotein A1
Time frame: Week 24 or Final Visit
Change from Baseline in apolipoprotein B
Time frame: Week 24 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Time frame: Week 24 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)
Time frame: Week 24 or Final Visit
Best corrected visual acuity
Time frame: Week 24 or Final Visit
Adverse Events
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Clinical Laboratory Tests
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Vital Signs
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24 or Final Visit
12-lead Electrocardiogram
Time frame: Weeks 12 and 24 or Final Visit
Physical Examination
Time frame: Week 24 or Final Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
- Results publication: PubMed 21518985Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 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.
Medical Director study director
Takeda
9 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 Lapaquistat acetate, Lapaquistat acetate and ezetimibe and Ezetimibe in people with Hypercholesterolemia, run by Takeda at 9 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 18 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Estonia, Latvia, Serbia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 fasting plasma Low Density Lipoprotein cholesterol (time frame: Week 24 or Final Visit). 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 NCT00268697, 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 24 May 2012.