Efficacy and Safety of Lapaquistat Acetate Coadministered With Atorvastatin in Subjects With Hypercholesterolemia
|Hypercholesterolemia||Drug: Lapaquistat acetate and atorvastatin Drug: Atorvastatin||Phase 2|
|Study Design:||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) Vs Placebo When Coadministered With Atorvastatin (10 or 20 mg) in Subjects With Primary Hypercholesterolemia|
- Percent change from Baseline in Low Density Lipoprotein Cholesterol [ Time Frame: Week 6 ]
- Percent change from Baseline in Total Cholesterol [ Time Frame: Week 6 ]
- Percent change from Baseline in High-Density Lipoprotein Cholesterol [ Time Frame: Week 6 ]
- Percent change from Baseline in Triglycerides [ Time Frame: Week 6 ]
- Percent change from Baseline in Apolipoprotein B [ Time Frame: Week 6 ]
- Percent change from Baseline in Apolipoprotein A1 [ Time Frame: Week 6 ]
- Percent change from Baseline in Very-Low Density Lipoprotein Cholesterol [ Time Frame: Week 6 ]
|Study Start Date:||September 2004|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
|Experimental: Lapaquistat Acetate 100 mg QD + Atorvastatin QD||
Drug: Lapaquistat acetate and atorvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
|Active Comparator: Atorvastatin QD||
Lapaquistat acetate placebo-matching tablets, orally, once daily and atorvastatin 10 mg or 20 mg, tablets, orally, once daily for up to 6 weeks.
Elevated plasma cholesterol (hypercholesterolemia) and various other plasma lipid imbalances (dyslipidemias) are major risk factors for coronary heart disease. Normally, the balance among cholesterol synthesis, dietary intake, and degradation is adequate to maintain healthy cholesterol plasma levels. However, in patients with hypercholesterolemia, elevation in low-density lipoprotein cholesterol leads to atherosclerotic deposition of cholesterol in the arterial walls. Consequently, it has been established that lowering the low-density lipoprotein cholesterol plasma concentration effectively reduces cardiovascular morbidity and mortality. As a result of this finding, the National Cholesterol Education Program Adult Treatment Panel III identifies control of low-density lipoprotein cholesterol as essential in the prevention and management of coronary heart disease. Additional lipid risk factors designated by Adult Treatment Panel III include elevated triglycerides, elevated non-high density lipoprotein cholesterol, and low levels of high-density lipoprotein cholesterol. Lipoproteins rich in triglycerides, such as very low-density lipoprotein cholesterol, appear to contribute to atherosclerosis, whereas the apparent protective effect of high-density lipoprotein cholesterol may be limited at low density lipoprotein concentrations.
TAK-475 (lapaquistat acetate) is a squalene synthase inhibitor currently under development at Takeda for the treatment of dyslipidemia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864643
|Study Director:||VP, Clinical Science Strategy||Takeda|