Status:
COMPLETED
Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia
Lead Sponsor:
Takeda
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term safety of lapaquistat acetate, once daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects with Hypercholeste...
Detailed Description
Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Normally, the balance among cholesterol ...
Eligibility Criteria
Inclusion
- Has completed the 01-04-TL-475-008 or 01-04-TL-475-009 study.
- 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 clinical laboratory evaluations within reference range for the testing laboratory at the previous visit in study 01-04-TL-475-008 or 01-04-TL-475-009 unless the results were deemed not clinically significant by the investigator or sponsor.
- Is willing and able to comply with a standardized low cholesterol diet.
- Is willing to continue taking the protocol-specified companion lipid-altering medication from the previous study (if applicable) for at least the first 4 weeks.
Exclusion
- Has an alanine aminotransferase or aspartate aminotransferase level greater than or equal to 3 times the upper limit of normal at the previous visit in the prior study, active liver disease, or jaundice.
- Has serum creatinine greater than or equal to 133 μmol/l at the previous visit in the prior study.
- Has a creatine kinase greater than or equal to 10 times the upper limit of normal at the previous visit in the prior study.
- Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion did not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.
- Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
- 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 status or was taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
- Has a known hypersensitivity to lapaquistat acetate.
- Has a history or presence of clinically significant food allergy that prevented them from maintaining Therapeutic Lifestyle Change (or equivalent) diet.
- Has a known homozygous familial hypercholesterolemia or known Type III hyperlipoproteinemia.
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension at Visit 1.
- 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 a history of alcohol abuse within the past 2 years.
- Has any other serious disease or condition at Visit 1 that may reduce life expectancy, impair successful management according to the protocol, or make the participant unsuitable to receive study medication.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Orlistat
- Sibutramine
- Isotretinoin
- Tacrolimus
- Probucol
- Systemic corticosteroids and androgens
- Potent cytochrome P-450 3A4 inhibitors
- Azole antifungal agents
- Cyclosporine
- Erythromycin
- Clarithromycin
- Human Immunodeficiency Virus protease inhibitors
- Amiodarone
- Verapamil
- Diltiazem
- Nefazodone
- Large quantities of grapefruit juice
- Warfarin
- Digoxin
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT00868127
Start Date
December 1 2005
End Date
July 1 2007
Last Update
May 24 2012
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