Hypertension (HTN) and dyslipidemia (DYS) commonly coexist. Patients with concurrent HTN and DYS are at high risk of cardiovascular disease, yet most patients do not achieve goals both for blood pressure and low-density lipoprotein-cholesterol (LDL-C). This randomized, double-blind, multicenter, placebo-controlled, 3x5 factorial study assessed the safety and efficacy of amlodipine/atorvastatin combination therapy on LDL-C and systolic blood pressure (SBP) levels versus either drug alone or placebo. Patients aged 18-75 years with concomitant HTN and DYS were treated for 8 weeks with amlodipine (5 or 10 mg), atorvastatin (10, 20, 40, or 80 mg), 8 combinations of these amlodipine/atorvastatin doses, or placebo. A total of 1660 patients were randomized. At baseline, mean (±SD) LDL-C was 182.0±25.5 mg/dL and mean SBP was 148.4±9.5 mmHg. All 8 amlodipine/atorvastatin dose combinations reduced LDL-C significantly more than placebo (range: 36.6-49.2%; all P< 0.001). Amlodipine 5 mg/atorvastatin 10 mg reduced LDL-C significantly more than atorvastatin 10 mg monotherapy (39.0% versus 33.5%; P< 0.01). Amlodipine 5 or 10 mg did not significantly affect LDL-C when administered in combination with any of the other atorvastatin doses. All 8 amlodipine/atorvastatin dose combinations lowered SBP significantly more than placebo (range: 12.6-17.5 mmHg; all P< 0.001). Adding atorvastatin to amlodipine did not affect the SBP-lowering efficacy of amlodipine. The majority of adverse events (AEs) were mild or moderate in intensity. A total of 83 (5.0%) patients discontinued due to AEs. The most common treatment-emergent AEs were peripheral edema (7.3%), headache (6.2%), and increased gamma-glutamyl-transferase levels (1.6%). The incidence of myalgia was low, at 1.6%. Coadministration of amlodipine and atorvastatin is efficacious at reducing SBP and LDL-C levels and safe when administered to patients with concomitant HTN and DYS.