Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia

NCT ID: NCT00532558

Last Updated: 2012-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 657 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-05-31

Brief Summary

The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).

Detailed Description

This study is being conducted to determine the potential of lapaquistat acetate 50 mg per day to lower LDL-C levels compared with placebo. This study is also being conducted to further evaluate the safety and tolerability of lapaquistat acetate 50 mg over a period of 12 weeks. An optional, 48-week, open-label extension will follow the 12 week, double-blind treatment period to evaluate the long-term safety and tolerability of lapaquistat acetate 50 mg/day.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lapaquistat Acetate 50 mg QD

Group Type: EXPERIMENTAL

Lapaquistat acetate

Intervention Type: DRUG

Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Lapaquistat acetate

Lapaquistat acetate 50 mg, tablets, orally, once daily for up to 12 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

TAK-475

Eligibility Criteria

Inclusion Criteria

• 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.
• Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 130 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.

Exclusion Criteria

• 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 fibrates within 42 days of Visit 1 or any lipid-lowering therapy for at least 30 days prior to Screening.
• 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.
• Has uncontrolled hypertension
• Has had inflammatory bowel disease or any other malabsorption syndrome, or has had gastric bypass or any other surgical procedure for weight loss.
• Has a history of drug abuse or a history of high alcohol intake within the previous 2 years.
• Has type 1 or 2 diabetes mellitus.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Tallinn, , Estonia

Tartu, , Estonia

Balatonfüred, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Érd, , Hungary

Pécs, , Hungary

Szekszárd, , Hungary

Beersheba, , Israel

Hadera, , Israel

Haifa, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Nahariya, , Israel

Safed, , Israel

Tel Aviv, , Israel

Daugavpils, , Latvia

Kuldīga, , Latvia

Riga, , Latvia

Amsterdam, , Netherlands

Breda, , Netherlands

GA Nijmegen, , Netherlands

Groningen, , Netherlands

Hoorn, , Netherlands

Rotterdam, , Netherlands

Utrecht, , Netherlands

Zoetermeer, , Netherlands

Ålesund, , Norway

Elverum, , Norway

Hamar, , Norway

Kongsberg, , Norway

Oslo, , Norway

Moscow, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Tyumen, , Russia

Volgograd, , Russia

Bratislava, , Slovakia

Dolný Kubín, , Slovakia

Košice, , Slovakia

Nitra, , Slovakia

Nové Mesto nad Váhom, , Slovakia

Trebišov, , Slovakia

Córdoba, , Spain

Madrid, , Spain

Pontevedra, , Spain

REUS (Tarragona), , Spain

Valencia, , Spain

Dnipro, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Lutsk, , Ukraine

Lviv, , Ukraine

Belfast, , United Kingdom

Bolton, , United Kingdom

Glasgow, Scotland, , United Kingdom

Oldham, , United Kingdom

Paignton, Devon, , United Kingdom

Sheffield, , United Kingdom

Countries

Estonia; Hungary; Israel; Latvia; Netherlands; Norway; Russia; Slovakia; Spain; Ukraine; United Kingdom

Other Identifiers

U1111-1122-8417

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-475_306

Identifier Type: -

Identifier Source: org_study_id