Study Stopped
Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents
Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in the Morning vs Lapaquistat Acetate 100 mg in the Evening vs Lapaquistat Acetate 50 mg Twice Daily vs Placebo in Subjects With Hypercholesterolemia
2 other identifiers
interventional
224
1 country
22
Brief Summary
The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedMay 24, 2012
May 1, 2012
4 months
March 18, 2009
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
Week 6
Secondary Outcomes (11)
Change from Baseline in Total Cholesterol
Week 6
Percent change from Baseline in apolipoprotein B
Week 6
Percent change from Baseline in apolipoprotein A1
Week 6
Change from Baseline in Triglycerides
Week 6
Percent change from Baseline in High-Density Lipoprotein Cholesterol
Week 6
- +6 more secondary outcomes
Study Arms (4)
Lapaquistat Acetate 100 mg QD (morning)
EXPERIMENTALLapaquistat Acetate 100 mg QD (evening)
EXPERIMENTALLapaquistat Acetate 50 mg BID
EXPERIMENTALPlacebo BID
PLACEBO COMPARATORInterventions
Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Eligibility Criteria
You may qualify if:
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Has prior to Randomization a mean low-density lipoprotein cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL for 2 consecutive samples.
- Has prior to Randomization mean triglycerides less than 400 mg/dL for 2 consecutive samples.
- Is willing and able to comply with a standardized, therapeutic lifestyle change diet or equivalent.
You may not qualify if:
- Has an alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of normal during the screening period.
- Has a serum creatinine greater than133 mmol/L during the screening period.
- Has a creatine phosphokinase greater than 3 times the upper limit of normal, identified during the screening period.
- Has active liver disease or jaundice.
- Has a history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
- Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
- Has a history of myocardial infarction, angina pectoris, unstable angina, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdomin al aorticaneurysm, coronary angioplasty, coronary or peripheral arterial surgery or multiple risk factors that confer a 10-year risk for cardiovascular disease greater than 20% based on Framingham risk scoring.
- Has a positive hepatitis B surface antigen, or antibody to hepatitis C virus, as determined by medical history and/or subject's verbal report.
- Has a positive human immunodeficiency virus status or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
- Has received any investigational compound within 30 days prior to screening Visit 1, or is currently participating in another investigational study.
- Has received lapaquistat acetate in a previous clinical study or as a therapeutic agent.
- 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.
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension despite treatment at Screening Visit 1.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (22)
Unknown Facility
Long Beach, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Margate City, New Jersey, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Perkasie, Pennsylvania, United States
Unknown Facility
Sellerville, Pennsylvania, United States
Unknown Facility
Bristol, Tennessee, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP, Clinical Science
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
March 18, 2009
First Posted
March 19, 2009
Study Start
July 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 24, 2012
Record last verified: 2012-05