Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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 Hypercholesterolemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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