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Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143663
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD).

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Lapaquistat Acetate Drug: Placebo Phase 3

Detailed Description:
This study will evaluate the efficacy and safety of TAK-475 (lapaquistat acetate) compared to placebo in subjects with primary hypercholesterolemia. Subjects who have signed the informed consent will undergo necessary evaluations to determine eligibility for a dietary run-in phase. Subjects who meet randomization criteria will enter treatment with one of the following randomized treatments: lapaquistat acetate or placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 100 mg Versus Placebo in Subjects With Primary Hypercholesterolemia
Study Start Date : September 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lapaquistat Acetate 100 mg QD Drug: Lapaquistat Acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks
Other Name: TAK-475

Placebo Comparator: Placebo QD Drug: Placebo
Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks




Primary Outcome Measures :
  1. Change from Baseline in Low-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]

Secondary Outcome Measures :
  1. Change from Baseline in Calculated Low-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  2. Change from Baseline in High-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  3. Change from Baseline in the ratio of Low-Density Lipoprotein cholesterol/ High-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  4. Change from Baseline in Very Low-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  5. Change from Baseline in non- High-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  6. Change from Baseline in Triglycerides [ Time Frame: Week 12 or Final Visit ]
  7. Change from Baseline in Total Cholesterol [ Time Frame: Week 12 or Final Visit ]
  8. Change from Baseline in the ratio of Total Cholesterol/High-Density Lipoprotein cholesterol [ Time Frame: Week 12 or Final Visit ]
  9. Change from Baseline in apolipoprotein A1 [ Time Frame: Week 12 or Final Visit ]
  10. Change from Baseline in apolipoprotein B [ Time Frame: Week 12 or Final Visit ]
  11. Change from Baseline in the ratio of apolipoprotein B/ apolipoprotein A1 [ Time Frame: Week 12 or Final Visit ]
  12. Change from Baseline in High-Sensitivity C-reactive Protein [ Time Frame: Week 12 or Final Visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female participants of childbearing potential cannot be been pregnant, lactating and are not planning on becoming pregnant and agrees to use acceptable forms of contraception throughout the course of this study.
  • Must have a mean low-density lipoprotein cholesterol values between 3.367 and 5.689 mmol/L, inclusive, from 2 consecutive samples taken at least 1 week apart with the difference between the 2 values not exceeding 15% of the higher value.
  • Must have a triglyceride value of 4.516 mmol/L or less from 2 consecutive samples taken at least 1 week apart with the upper value from either sample being 5.081 mmol/L or less.
  • Has clinical laboratory evaluations within the reference ranges for the testing laboratory unless the results were deemed not clinically significant by the investigator or sponsor.
  • Is willing and able to maintain a standardized low-cholesterol diet.

Exclusion Criteria:

  • 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.
  • Has a creatine phosphokinase value greater than three times the upper limit of normal.
  • Has diabetes mellitus type 1 or 2.
  • Has a history of cancer that had been in remission for less than 5 years prior to the first dose of study drug. This criterion did not include subjects with basal cell or stage I squamous cell carcinoma of the skin.
  • Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
  • Has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple risk factors that present a 10-year risk for CHD of greater than 20%, based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or participant's verbal report.
  • Has a positive human immunodeficiency virus test result 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.
  • Has had exposure to lapaquistat acetate in other studies or was participating or enrolled in another investigational study within the previous 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 history or presence of a clinically significant food allergy that would prevent adherence to the therapeutic lifestyle change (or equivalent) diet.
  • Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
  • Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
  • Has uncontrolled hypertension.
  • 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 alcohol abuse within the past 2 years.
  • Has any other serious disease or condition at Run-In or at Randomization that might reduce life expectancy, impair successful management according to the protocol, or make the subject an unsuitable candidate to receive study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143663


Locations
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United States, Alabama
Northport, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
United States, California
Chula Vista, California, United States
Encinitas, California, United States
Long Beach, California, United States
Pismo Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
United States, Colorado
Golden, Colorado, United States
United States, Florida
Aventura, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
New Port Richy, Florida, United States
Pembroke Pines, Florida, United States
United States, Illinois
Elk Grove Village, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Arkansas City, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Michigan
Livonia, Michigan, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Margate, New Jersey, United States
United States, New York
New Hyde Park, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Oregon
Medford, Oregon, United States
United States, Pennsylvania
Downingtown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Tipton, Pennsylvania, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Utah
Ogden, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
Publications of Results:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00143663    
Other Study ID Numbers: 01-04-TL-475-008
U1111-1122-7722 ( Registry Identifier: WHO )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012
Keywords provided by Takeda:
Hypercholesterolemia
Hyperlipidemia
Drug Therapy
Additional relevant MeSH terms:
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Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases