Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia

NCT00532311 | Terminated Phase 3

• 2 other identifiers: TAK-475_307U1111-1122-8479
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 86

Brief Summary

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia

Conditions

Hypercholesterolemia

Keywords

Hyperlipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol

  Week 12 or Final Visit

Secondary Outcomes (14)

• Change from Baseline in Triglycerides

  Week 12 or Final Visit

• Change from Baseline in Total Cholesterol

  Week 12 or Final Visit

• Change from Baseline in High Density Lipoprotein cholesterol

  Week 12 or Final Visit

• Change from Baseline in Very Low Density Lipoprotein cholesterol

  Week 12 or Final Visit

• Change from Baseline in apolipoprotein A1

  Week 12 or Final Visit

Study Arms (2)

Lapaquistat Acetate 50 mg QD

EXPERIMENTAL

(and stable statin therapy)

Drug: Lapaquistat acetate and stable statin therapy

Stable statin therapy

ACTIVE COMPARATOR

Drug: Stable statin therapy

Interventions

Lapaquistat acetate and stable statin therapy DRUG

Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.

Also known as: TAK-475, Lipitor, Zocor, Crestor, Pravachol, Lescol, Mevacor

Lapaquistat Acetate 50 mg QD

Stable statin therapy DRUG

Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.

Also known as: Lipitor, Zocor, Crestor, Pravachol, Lescol, Mevacor

Stable statin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 been on a stable dose of statin for at least 3 months prior to Screening. Participants enrolled in Canada, Latin America, and South Africa must be on the maximum approved dose of statin (atorvastatin 80 mg, simvastatin 80 mg, rosuvastatin 40 mg, pravastatin 80 mg, fluvastatin 80 mg, or lovastatin 80 mg).
• Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2 consecutive samples.
• Prior to Randomization, the subject has mean triglyceride level greater than or equal to 400 mg/dL for 2 consecutive samples.
• Is willing and able to comply with the recommended, standardized diet.

You may not qualify if:

• Has an nine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, identified during screening.
• Has a serum creatinine greater than 133 mmol/L, identified during screening.
• Has a creatine kinase greater than 3 times the upper limit of normal, identified during screening.
• Has active liver disease or jaundice.
• Has taken any bile acid sequestrants \[eg, cholestyramine\], and intestinal cholesterol uptake inhibitors \[eg, ezetimibe\]) from 30 days before Screening until study completion or any fibrates for 6 weeks before Visit 1.
• Has a previous 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's 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, abdominal aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or multiple risk factors that confer a 10-year risk for cardiovascular heart disease greater than 20% based on Framingham risk scoring.
• Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as determined by medical history.
• 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 medication 30 days prior to screening, (for drugs with a long half-life, within a period of less than 5 times the drug's half-life) or is participating in an 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 (familial dysbetalipoproteinemia).
• Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.

Sponsors & Collaborators

• Takeda: lead

Study Sites (86)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Tuscaloosa, Alabama, United States

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Glendale, Arizona, United States

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Tucson, Arizona, United States

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Artesia, California, United States

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Long Beach, California, United States

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Santa Ana, California, United States

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Santa Rosa, California, United States

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Tustin, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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Washington D.C., District of Columbia, United States

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Coral Gables, Florida, United States

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Fort Meyers, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, 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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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Pinellas Park, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Dunwoody, Georgia, United States

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Idaho Falls, Idaho, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, 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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CantonAuburn, Maine, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Haverhill, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Edina, Minnesota, United States

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Olive Branch, Mississippi, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Margate City, New Jersey, United States

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Wilwood, New Jersey, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, 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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Kettering, Ohio, United States

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Mentor, Ohio, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Dowington, Pennsylvania, United States

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Sellerville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Goose Creek, South Carolina, United States

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Greer, 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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Bristol, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Wauwatosa, Wisconsin, United States

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MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

1-((1-(3-acetoxy-2,2-dimethylpropyl)-7-chloro-5-(2,3-dimethoxyphenyl)-2-oxo-1,2,3,5-tetrahydro-4,1-benzoxazepin-3-yl)acetyl)piperidine-4-acetic acid; Atorvastatin; Simvastatin; Rosuvastatin Calcium; Pravastatin; Fluvastatin; Lovastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

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: September 18, 2007
• First Posted: September 20, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

US (86)