HypercholesterolemiaPhase 3NCT00143676
Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia
A Phase 3 study testing Lapaquistat acetate and atorvastatin and Atorvastatin in people with Hypercholesterolemia, run by Takeda at 78 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin. 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 and atorvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 78 sitesUnited States
- Study dates
- Aug 2005to Aug 2006
- 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
- Female subjects of childbearing potential must not be pregnant as determined by a negative serum human chorionic gonadotropin, lactating, or planning on becoming pregnant, and agrees to use acceptable forms of contraception during the study.
- Must have a mean low density lipoprotein cholesterol value greater than or equal to 2.590 mmol/L (100 mg/dL) for 2 consecutive samples
- Must have a mean triglyceride value less than or equal to 4.516 mmol/L (400 mg/dL) for 2 consecutive samples.
- Has taken a stable dose of atorvastatin (10 to 40 mg)
- Has clinical laboratory evaluations within reference range for the testing laboratory.
- Is willing and able to continue to comply with a standardized low-cholesterol diet.
Who cannot join
- Has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
- Has a serum creatinine level greater than 135 μmol/L (1.5 mg/dL).
- Has a creatine phosphokinase level greater than 3 times the upper limit of normal
- Has diabetes with a hemoglobin A1c level greater than 8% at Visit 1.
- Has a history of cancer in remission for less than 5 years prior to the first dose of study drug.
- Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
Show all 18Show fewer
- Has a history of myocardial infarction, unstable angina, transient ischemic attacks, cerebrovascular accident, percutaneous coronary intervention, or coronary or peripheral arterial surgery.
- 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 had exposure to lapaquistat acetate in other studies, was 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.
- Has a known hypersensitivity or history of adverse reaction to atorvastatin.
- Has a history or presence of clinically significant food allergy that would prevent adherence to the recommended diet.
- Has a known homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia.
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension
- Has inflammatory bowel disease or any other malabsorption syndrome or has 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 that might reduce life expectancy, impair successful management according to the protocol, or make the subject an unsuitable candidate to receive study drug.
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Study site
Allentown, Pennsylvania
Study site
Altoona, Pennsylvania
Study site
Anaheim, California
Study site
Arkansas City, Kansas
Study site
Arlington Heights, Illinois
Study site
Auburn, Maine
Study site
Birmingham, Alabama
Study site
Bloomington, Indiana
Study site
Carmichael, California
Study site
Charleston, South Carolina
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
Downingtown, Pennsylvania
Study site
Edina, Minnesota
Study site
Edison, New Jersey
Study site
Escondido, California
Study site
Euless, Texas
Study site
Evansville, Indiana
Study site
Golden, Colorado
Study site
Hickory, North Carolina
Study site
Hollywood, Florida
Study site
Honolulu, Hawaii
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Jonesboro, Arkansas
Study site
Jupiter, Florida
Study site
Kansas City, Kansas
Study site
Kissimmee, Florida
Study site
Las Vegas, Nevada
Study site
Livonia, Michigan
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Margate City, New Jersey
Study site
Medford, Oregon
Study site
Miami, Florida
Study site
Morristown, Tennessee
Study site
Mt. Pleasant, South Carolina
Study site
New Hyde Park, New York
Study site
New Port Richey, Florida
Study site
Norfolk, Virginia
Study site
Northport, Alabama
Study site
Ocala, Florida
Study site
Ogden, Utah
Study site
Omaha, Nebraska
Study site
Overland Park, Kansas
Study site
Pembroke Pines, Florida
Study site
Peoria, Illinois
Study site
Pismo Beach, California
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Renton, Washington
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Rosa, California
Study site
Searcy, Arkansas
Study site
Sellerville, Pennsylvania
Study site
Sierra Vista, Arizona
Study site
Simpsonville, South Carolina
Study site
Statesville, North Carolina
Study site
Syracuse, New York
Study site
The Colony, Texas
Study site
Tipton, Pennsylvania
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Warwick, Rhode Island
Study site
Waterbury, Connecticut
Study site
Waterloo, Iowa
Study site
West Palm Beach, Florida
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
About this study
Official title: A Double-blind, Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of TAK-475 50 mg, 100 mg, or Placebo When Co-administered With Atorvastatin (10 mg to 40 mg) in Subjects With Primary Hypercholesterolemia
The purpose of this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin.
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.
TGRD 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 assess the effects of co-administration of lapaquistat acetate with atorvastatin, the most commonly prescribed statin in the United States, on LDL-C and associated lipid variables in subjects with hypercholesterolemia. Study Participation is anticipated to be up to 24 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Lapaquistat acetate and atorvastatin, Atorvastatin
- 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 atorvastatinDrug
Also called Lapaquistat, Lipitor, TAK-475
Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
Lapaquistat acetate and atorvastatinDrug
Also called Lapaquistat, Lipitor, TAK475
Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
AtorvastatinDrug
Also called Lipitor
Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lapaquistat Acetate 50 mg QD + Atorvastatin | Experimental | Not described Receives: Drug: Lapaquistat acetate and atorvastatin |
| Lapaquistat Acetate 100 mg QD + Atorvastatin | Experimental | Not described Receives: Drug: Lapaquistat acetate and atorvastatin |
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
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 24 or Final Visit
Secondary outcomes (20)
Adverse Events
Measured: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Physical Examination
Measured: Week 24 or Final Visit
Safety Laboratory Tests
Measured: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Electrocardiogram assessments
Measured: Week 24 or Final Visit
Best Corrected Visual Acuity results
Measured: Week 24 or Final Visit
Vital Signs
Measured: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
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 1.813 mmol/L (70 mg/dL)
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.590 mmol/L (100 mg/dL)
Measured: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.367 mmol/L (130 mg/dL)
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 posted2 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2006
- Study completionAug 2006
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
- 448 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
- NCT00143676
- Sponsor's protocol ID
- 01-04-TL-475-009
- Other IDs
- U1111-1122-7783
- Status last verified
- May 2012
- First submitted
- 31 Aug 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, Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of TAK-475 50 mg, 100 mg, or Placebo When Co-administered With Atorvastatin (10 mg to 40 mg) in Subjects With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00143676
- Acronym / sponsor ID
- 01-04-TL-475-009
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia, Dyslipidemia, Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 2 Sep 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 this study is to determine the efficacy of lapaquistat acetate, once daily (QD), on lowering cholesterol in subjects already taking atorvastatin.
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.
TGRD 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 assess the effects of co-administration of lapaquistat acetate with atorvastatin, the most commonly prescribed statin in the United States, on LDL-C and associated lipid variables in subjects with hypercholesterolemia. Study Participation is anticipated 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 50 mg QD + Atorvastatin | Experimental | Drug: Lapaquistat acetate and atorvastatin |
| Lapaquistat Acetate 100 mg QD + Atorvastatin | Experimental | Drug: Lapaquistat acetate and atorvastatin |
| Atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female subjects of childbearing potential must not be pregnant as determined by a negative serum human chorionic gonadotropin, lactating, or planning on becoming pregnant, and agrees to use acceptable forms of contraception during the study.
- Must have a mean low density lipoprotein cholesterol value greater than or equal to 2.590 mmol/L (100 mg/dL) for 2 consecutive samples
- Must have a mean triglyceride value less than or equal to 4.516 mmol/L (400 mg/dL) for 2 consecutive samples.
- Has taken a stable dose of atorvastatin (10 to 40 mg)
- Has clinical laboratory evaluations within reference range for the testing laboratory.
Key exclusion criteria (18 listed)
- Has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
- Has a serum creatinine level greater than 135 μmol/L (1.5 mg/dL).
- Has a creatine phosphokinase level greater than 3 times the upper limit of normal
- Has diabetes with a hemoglobin A1c level greater than 8% at Visit 1.
- Has a history of cancer in remission for less than 5 years prior to the first dose of study drug.
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 atorvastatinAlso: Lapaquistat, Lipitor, TAK-475Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. | Drug | Lapaquistat Acetate 50 mg QD + Atorvastatin |
| Lapaquistat acetate and atorvastatinAlso: Lapaquistat, Lipitor, TAK475Lapaquistat acetate 100 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. | Drug | Lapaquistat Acetate 100 mg QD + Atorvastatin |
| AtorvastatinAlso: LipitorLapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. | Drug | Atorvastatin |
Primary outcome
Change from Baseline in Low Density Lipoprotein cholesterol
Time frame: Week 24 or Final Visit
20 secondary outcomes
Adverse Events
Time frame: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Physical Examination
Time frame: Week 24 or Final Visit
Safety Laboratory Tests
Time frame: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Electrocardiogram assessments
Time frame: Week 24 or Final Visit
Best Corrected Visual Acuity results
Time frame: Week 24 or Final Visit
Vital Signs
Time frame: Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
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 1.813 mmol/L (70 mg/dL)
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.590 mmol/L (100 mg/dL)
Time frame: Week 24 or Final Visit
Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.367 mmol/L (130 mg/dL)
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
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lapaquistat acetate and atorvastatin and Atorvastatin in people with Hypercholesterolemia, run by Takeda at 78 sites in United States.
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 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 78 sites in United States. 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 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 NCT00143676, 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.