Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia

Conditions
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Hypertension, Hypercholesterolemia, Angina Pectoris

Intervention / Treatment
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* Drug: Caduet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caduet<br> | Drug: Caduet<br>* One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Value at each visits minus value at baseline | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia | Value at each visits minus value at baseline | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia | Value at each visits minus value at baseline | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia | Value at each visits minus value at baseline | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | 
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 | Weeks 4, 12, 24, and 52 | 
| Percent Change From Baseline in Total Cholesterol (TC) at Each Visit | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 | Weeks 4, 12, 24, and 52 | 
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 | Weeks 4, 12, 24, and 52 | 
| Percent Change From Baseline in Triglyceride (TG) at Each Visit | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 | Week 4, 12, 24, and 52 | 
| Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Value at each visits minus value at baseline | Weeks 4, 12, 24, and 52 | 
| Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit | Value at each visits minus value at baseline | Weeks 4, 12, 24, and 52 | 
| Percent Change From Baseline in Apolipoprotein B at Each Visit | Value at each visits minus value at baseline divided by value at baseline multiplied by 100 | Week 4, 12, 24, and 52 |