NCT00530946.

Methods	Randomised open‐label, parallel trial
Participants	The outpatient with concurrent hypertension and hyper‐LDL‐cholesterolemia is a male or female >= 20 to < 80 years of age at Visit 1.The SBP at Visit 4 (Week ‐1) and Visit 5 (Week 0) is continuously SBP >= 140 mmHg and < 180 mmHg, LDL‐C >= 140 mg/dL and < 250 mg/dL at Visit 3 (Week ‐2) and 4 (Week ‐1)
Interventions	Drug: amlodipine 2.5 mg/atorvastatin 5 mg (single pill combination, dosed once daily for 8 weeks) Drug: amlodipine 2.5mg/atorvastatin 10mg (single pill combination, dosed once daily for 8 weeks) Drug: amlodipine 5 mg/atorvastatin 5 mg (single pill combination, dosed once daily for 8 weeks) Drug: amlodipine 5 mg/atorvastatin 10 mg (single pill combination, dosed once daily for 8 weeks) Comparator: active comparator: CI‐1038 2.5 mg/5 mg (intervention: drug: amlodipine 2.5 mg/atorvastatin 5 mg) active comparator: CI‐1038 2.5 mg/10 mg (intervention: drug: amlodipine 2.5 mg/atorvastatin 10 mg) active comparator: CI‐1038 5 mg/5 mg (intervention: drug: amlodipine 5 mg/atorvastatin 5 mg) active comparator: CI‐1038 5 mg/10 mg (intervention: drug: amlodipine 5 mg/atorvastatin 10 mg)
Outcomes	Primary outcomes: Change in SBP, Percent Change in LDL Secondary outcomes: Change in SBP from baseline to each observation point (4 weeks and 8weeks) Change in DBP from baseline to each observation point (4 weeks, 8 weeks) Percent change in LDL, total cholesterol, HDL, triglycerides, from baseline to each observation point Change in LDL/HDL ratio (timeframe 2 weeks, 4 weeks, 8 weeks), change in total cholesterol/HDL (timeframe 2 weeks, 4 weeks, 8 weeks) ‐Change in apolipoprotein B From baseline to each observation point ((timeframe 2 weeks, 4 weeks, 8 weeks)
Notes