HypercholesterolemiaPhase 3NCT00263081
Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial Hypercholesterolemia
A Phase 3 study testing Lapaquistat acetate and current lipid-lowering treatment and Current lipid-lowering treatment in people with Hypercholesterolemia, run by Takeda at 10 sites in 6 countries.
Trial summary
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia undergoing lipid-lowering treatment. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lapaquistat acetate and current lipid-lowering treatment and Current lipid-lowering treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Nov 2005to Mar 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be at least 8 years of age (12 years of age in Poland) and weigh greater than or equal to 30 kg.
- Must have homozygous FH, as documented by genetic testing that confirmed 2 mutated alleles at the LDL-receptor locus, or by the following clinical criteria:
- documented history of untreated fasting serum LDL-C >460 mg/dL (11.91 mmol/L).
- tendinous or cutaneous xanthomas and/or corneal arcus before age 10 and/or premature coronary heart disease before age 20.
- Must be taking a stable, approved lipid-lowering drug regimen for a minimum of 8 weeks prior to Screening Visit 1 and were to continue that treatment for the duration of the study.
- Female participants can not be pregnant, not lactating, not planning on becoming pregnant and agree to use adequate contraception throughout the course of the study.
Who cannot join
- Has alanine aminotransferase or aspartate aminotransferase levels greater than 2 times the upper limit of normal, active liver disease, jaundice, or serum creatinine >135 μmol/L (1.5 mg/dL) at screening.
- Has a creatine kinase greater than 3 times the upper limit of normal
- Has a positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history.
- Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
- Is unable or unwilling to discontinue excluded medications or to continue stable doses of 'stable dose' medications or would require treatment with any excluded medication during the study.
- Is currently participating in another investigational study or 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 14Show fewer
- Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study drug. This criterion was not to include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.
- Has known hypersensitivity or history of adverse reaction to lapaquistat acetate.
- Has a history of fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has an endocrine disorder, such as Cushing Syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism. Subjects with hypothyroidism on appropriate replacement therapy.
- Has uncontrolled hypertension despite medical treatment.
- Has inflammatory bowel disease or any other malabsorption syndrome or had gastric bypass or any other surgical procedure for weight loss.
- Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
- Has any other serious disease or condition at screening or at randomization that might have reduced life expectancy, impaired successful management according to the protocol, or made the subject an unsuitable candidate to receive study drug.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States2 sites
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 or Placebo When Co-administered With Current Lipid-lowering Therapy in Subjects With Homozygous Familial Hypercholesterolemia.
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia undergoing lipid-lowering treatment.
Read the detailed description
According to the World Health Organization, CHD is now the leading cause of death worldwide. In 2001, CHD caused 7.2 million deaths and estimates for 2020 indicate that annual CHD deaths will increase to 11.1 million. These statistics suggest that improved options are needed to treat hypercholesterolemia and dyslipidemia.
The balance among cholesterol synthesis, dietary intake, and degradation is normally adequate to maintain healthy cholesterol plasma levels. However, in patients with hypercholesterolemia, elevated low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls. Consequently, in this population it has been established that lowering low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. The National Cholesterol Education Program Adult Treatment Panel III has therefore identified control of low-density lipoprotein cholesterol as essential in the prevention and management of CHD. Additional lipid risk factors designated by National Cholesterol Education Program Adult Treatment Panel III include elevated triglycerides, elevated non-high-density lipoprotein cholesterol (atherogenic lipoproteins), and low levels of high-density lipoprotein cholesterol. Lipoproteins rich in triglycerides, such as very-low-density lipoprotein cholesterol, appear to contribute to atherosclerosis, whereas the apparent protective effect of high-density lipoprotein cholesterol, which is likely related to high-density lipoprotein cholesterol-facilitated transport of cholesterol away from atherosclerotic deposits, may be limited at low high-density lipoprotein cholesterol concentrations.
Initial dietary and lifestyle measures taken to control dyslipidemia are often inadequate, and most patients require pharmacologic intervention. Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) are the first-line monotherapies most often prescribed to reduce low-density lipoprotein cholesterol, after diet and therapeutic lifestyle change. However, with statin monotherapy, many patients fail to reach National Cholesterol Education Program Adult Treatment Panel III recommended levels of low-density lipoprotein cholesterol reduction. As a result, the statin dosage must be increased or an additional treatment added to achieve treatment goals. Increasing the statin dosage may result in decreased tolerability and potential safety concerns, contributing to the high discontinuation rates of statins and their prescription at low and often ineffective doses. Further, although the effectiveness of increasing the dose varies among the statins, in general, doubling of the dose above the minimum effective dose has been found to decrease serum low-density lipoprotein cholesterol by only an additional 6 percent.
Takeda Global Research and Development Center, Inc. is developing an orally active squalene synthase inhibitor, TAK-475 (lapaquistat acetate) for the treatment of dyslipidemia. Lapaquistat acetate inhibits the biosynthesis of cholesterol by inhibiting the enzyme squalene synthase, which catalyzes the conversion of farnesyl diphosphate to squalene-a precursor in the final steps of cholesterol production.
This study will evaluate the efficacy of lapaquistat acetate coadministered with ongoing lipid-lowering therapy in treating subjects with homozygous familial hypercholesterolemia. The effect on LDL-C and other lipid parameters, as well as the safety and tolerability of lapaquistat acetate compared to a placebo will be evaluated during a 12-week double-blind treatment period. The long-term safety of lapaquistat acetate treatment in this population will be evaluated during an open-label extension period. Study Participation is anticipated to be up to 3 years.
- Conditions
- Hypercholesterolemia
- Being tested
- Lapaquistat acetate and current lipid-lowering treatment, Current lipid-lowering treatment
- Keywords
- Hyperlipidemia, Dyslipidemia, Drug Therapy
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapaquistat acetate and current lipid-lowering treatmentDrug
Also called Lapaquistat, TAK-475
Cohort 1: Weight is less than 50 kg:
Lapaquistat acetate 50 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
Cohort 2: Weight is more than 50 kg:
Lapaquistat acetate 100 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
Current lipid-lowering treatmentDrug
Lapaquistat acetate placebo-matching tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lapaquistat Acetate QD | Experimental | (and current lipid-lowering treatment) Receives: Drug: Lapaquistat acetate and current lipid-lowering treatment |
| Current lipid-lowering treatment | Placebo comparator | Not described Receives: Drug: Current lipid-lowering treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Low Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Secondary outcomes (12)
Change from Baseline in calculated Low Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in Triglycerides
Measured: Week 12 or Final Visit
Change from Baseline in Total Cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in apolipoprotein A1
Measured: Week 12 or Final Visit
Change from Baseline in apolipoprotein B
Measured: Week 12 or Final Visit
Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Measured: Week 12 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Measured: Week 12 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Measured: Week 12 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 posted7 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents
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
- 44 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
- NCT00263081
- Sponsor's protocol ID
- 01-05-TL-475-016
- Other IDs
- 2005-003626-26, U1111-1122-7919, 2005
- Status last verified
- May 2012
- First submitted
- 6 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, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 or Placebo When Co-administered With Current Lipid-lowering Therapy in Subjects With Homozygous Familial Hypercholesterolemia.
- ClinicalTrials.gov ID
- NCT00263081
- Acronym / sponsor ID
- 01-05-TL-475-016
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia, Dyslipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents
- Enrolment
- 44 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 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), to lower cholesterol in subjects with homozygous familial hypercholesterolemia undergoing lipid-lowering treatment.
Detailed description
According to the World Health Organization, CHD is now the leading cause of death worldwide. In 2001, CHD caused 7.2 million deaths and estimates for 2020 indicate that annual CHD deaths will increase to 11.1 million. These statistics suggest that improved options are needed to treat hypercholesterolemia and dyslipidemia.
The balance among cholesterol synthesis, dietary intake, and degradation is normally adequate to maintain healthy cholesterol plasma levels. However, in patients with hypercholesterolemia, elevated low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls. Consequently, in this population it has been established that lowering low-density lipoprotein cholesterol plasma concentrations effectively reduces cardiovascular morbidity and mortality. The National Cholesterol Education Program Adult Treatment Panel III has therefore identified control of low-density lipoprotein cholesterol as essential in the prevention and management of CHD. Additional lipid risk factors designated by National Cholesterol Education Program Adult Treatment Panel III include elevated triglycerides, elevated non-high-density lipoprotein cholesterol (atherogenic lipoproteins), and low levels of high-density lipoprotein cholesterol. Lipoproteins rich in triglycerides, such as very-low-density lipoprotein cholesterol, appear to contribute to atherosclerosis, whereas the apparent protective effect of high-density lipoprotein cholesterol, which is likely related to high-density lipoprotein cholesterol-facilitated transport of cholesterol away from atherosclerotic deposits, may be limited at low high-density lipoprotein cholesterol concentrations.
Initial dietary and lifestyle measures taken to control dyslipidemia are often inadequate, and most patients require pharmacologic intervention. Currently, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) are the first-line monotherapies most often prescribed to reduce low-density lipoprotein cholesterol, after diet and therapeutic lifestyle change. However, with statin monotherapy, many patients fail to reach National Cholesterol Education Program Adult Treatment Panel III recommended levels of low-density lipoprotein cholesterol reduction. As a result, the statin dosage must be increased or an additional treatment added to achieve treatment goals. Increasing the statin dosage may result in decreased tolerability and potential safety concerns, contributing to the high discontinuation rates of statins and their prescription at low and often ineffective doses. Further, although the effectiveness of increasing the dose varies among the statins, in general, doubling of the dose above the minimum effective dose has been found to decrease serum low-density lipoprotein cholesterol by only an additional 6 percent.
Takeda Global Research and Development Center, Inc. is developing an orally active squalene synthase inhibitor, TAK-475 (lapaquistat acetate) for the treatment of dyslipidemia. Lapaquistat acetate inhibits the biosynthesis of cholesterol by inhibiting the enzyme squalene synthase, which catalyzes the conversion of farnesyl diphosphate to squalene-a precursor in the final steps of cholesterol production.
This study will evaluate the efficacy of lapaquistat acetate coadministered with ongoing lipid-lowering therapy in treating subjects with homozygous familial hypercholesterolemia. The effect on LDL-C and other lipid parameters, as well as the safety and tolerability of lapaquistat acetate compared to a placebo will be evaluated during a 12-week double-blind treatment period. The long-term safety of lapaquistat acetate treatment in this population will be evaluated during an open-label extension period. Study Participation is anticipated to be up to 3 years.
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 |
|---|---|---|
| Lapaquistat Acetate QD | Experimental | Drug: Lapaquistat acetate and current lipid-lowering treatment(and current lipid-lowering treatment) |
| Current lipid-lowering treatment | Placebo comparator | Drug: Current lipid-lowering treatment |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Must be at least 8 years of age (12 years of age in Poland) and weigh greater than or equal to 30 kg.
- Must have homozygous FH, as documented by genetic testing that confirmed 2 mutated alleles at the LDL-receptor locus, or by the following clinical criteria:
- Must be taking a stable, approved lipid-lowering drug regimen for a minimum of 8 weeks prior to Screening Visit 1 and were to continue that treatment for the duration of the study.
- Female participants can not be pregnant, not lactating, not planning on becoming pregnant and agree to use adequate contraception throughout the course of the study.
Key exclusion criteria (14 listed)
- Has alanine aminotransferase or aspartate aminotransferase levels greater than 2 times the upper limit of normal, active liver disease, jaundice, or serum creatinine >135 μmol/L (1.5 mg/dL) at screening.
- Has a creatine kinase greater than 3 times the upper limit of normal
- Has a positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history.
- Has a positive human immunodeficiency virus status or was taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
- Is unable or unwilling to discontinue excluded medications or to continue stable doses of 'stable dose' medications or would require treatment with any excluded medication during the study.
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 acetate and current lipid-lowering treatmentAlso: Lapaquistat, TAK-475Cohort 1: Weight is less than 50 kg: Lapaquistat acetate 50 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks. Cohort 2: Weight is more than 50 kg: Lapaquistat acetate 100 mg, tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks. | Drug | Lapaquistat Acetate QD |
| Current lipid-lowering treatmentLapaquistat acetate placebo-matching tablets, orally, once daily and current lipid-lowering treatment for up to 12 weeks. | Drug | Current lipid-lowering treatment |
Primary outcome
Change from Baseline in Low Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
12 secondary outcomes
Change from Baseline in calculated Low Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in non- High Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in Triglycerides
Time frame: Week 12 or Final Visit
Change from Baseline in Total Cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in High Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in Very Low Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in apolipoprotein A1
Time frame: Week 12 or Final Visit
Change from Baseline in apolipoprotein B
Time frame: Week 12 or Final Visit
Lipoprotein cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol
Time frame: Week 12 or Final Visit
Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B
Time frame: Week 12 or Final Visit
Change from Baseline in high-sensitivity C-reactive protein
Time frame: Week 12 or Final Visit
Results and safety
The study was stopped early (reason given: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents). Results are not available in the source record.
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
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lapaquistat acetate and current lipid-lowering treatment and Current lipid-lowering treatment in people with Hypercholesterolemia, run by Takeda at 10 sites in 6 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 14 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: stopped early, 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 10 sites in Poland, United States, France, Canada, Israel and 1 more country. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents). Results are not available in the source record.
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 Low Density Lipoprotein cholesterol (time frame: Week 12 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 NCT00263081, 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.