Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5
 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in
 Japanese patients with both of hypertension and hypercholesterolemia, or with both angina
 pectoris and hypercholesterolemia.
Inclusion Criteria:

 -  Subject with both hypertension and hypercholesterolemia must meet the following (1),
 and the following (2) or (3):

 -  (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2,
 and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)

 -  (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2

 -  (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3
 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and
 TG < 400 mg/dL at Week -2

 -  Subject with both angina pectoris and hypercholesterolemia must meet the following
 (1), and the following (2) or (3):

 -  (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2,
 and who meet the following criteria; Subjects with well controlled BP value (BP value
 < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris

 -  (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2

 -  (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3
 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and
 TG < 400 mg/dL at Week -2

 Exclusion Criteria:

 -  Subjects who need three or more multi-antihypertensive therapies to achieve the target
 BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is
 defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.

 -  Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥
 160 mg/dL even though Atorvastatine 10 mg has administrated