Safety of Lapaquistat Acetate in Subjects With Hypercholesterolemia

PHASE3CompletedINTERVENTIONAL
Enrollment

574

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

July 31, 2007

Study Completion Date

July 31, 2007

Conditions
Hypercholesterolemia
Interventions
DRUG

Lapaquistat acetate

"Participants from 01-04-TL-475-008 Monotherapy Study:~Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 48 weeks."

DRUG

Lapaquistat acetate and additional lipid-lowering therapy

"Participants from 01-04-TL-475-009 Atorvastatin Add-on Study:~Lapaquistat acetate 100 mg, tablets, orally, once daily and current Atorvastatin therapy for up to 4 weeks.~Then, Lapaquistat 100 mg, tablets, orally, once daily and dose adjustment of Atorvastatin OR additional companion lipid-lowering therapy as needed for target LDL-C for up to 42 weeks."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY