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:
Secondary outcomes:
|
Notes |