Efficacy of Lapaquistat Acetate and Atorvastatin on Blood Cholesterol Levels in Subjects With Primary Hypercholesterolemia
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
2 other identifiers
interventional
448
1 country
78
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2005
Shorter than P25 for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMay 24, 2012
May 1, 2012
1 year
August 31, 2005
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Low Density Lipoprotein cholesterol
Week 24 or Final Visit
Secondary Outcomes (20)
Adverse Events
Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Physical Examination
Week 24 or Final Visit
Safety Laboratory Tests
Weeks: 2, 4, 8, 12, 16, 20, and 24 or Final Visit
Electrocardiogram assessments
Week 24 or Final Visit
Best Corrected Visual Acuity results
Week 24 or Final Visit
- +15 more secondary outcomes
Study Arms (3)
Lapaquistat Acetate 50 mg QD + Atorvastatin
EXPERIMENTALLapaquistat Acetate 100 mg QD + Atorvastatin
EXPERIMENTALAtorvastatin
ACTIVE COMPARATORInterventions
Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (78)
Unknown Facility
Birmingham, Alabama, United States
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Northport, Alabama, United States
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Sierra Vista, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Searcy, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Pismo Beach, California, United States
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Santa Rosa, California, United States
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Golden, Colorado, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Daytona Beach, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Bloomington, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Waterloo, Iowa, United States
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Arkansas City, Kansas, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Auburn, Maine, United States
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Livonia, Michigan, United States
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Edina, Minnesota, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Edison, New Jersey, United States
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Margate City, New Jersey, United States
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New Hyde Park, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Sellerville, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Morristown, Tennessee, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Euless, Texas, United States
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San Antonio, Texas, United States
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The Colony, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Renton, Washington, United States
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Madison, Wisconsin, United States
Related Publications (1)
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.
PMID: 21518985RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
August 1, 2005
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
May 24, 2012
Record last verified: 2012-05