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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Healthcare Corporation MEDOC Medical Dock&Clinic
Nagoya, Aichi-ken, Japan
Beppu Medical Clinic
Dazaifu, Fukuoka, Japan
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.
Time frame: 52 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Morizono medical clinic
Kitakyushu, Fukuoka, Japan
Gakkentoshi Clinic
Nishiku, Fukuoka, Japan
Department of internal gastro-intestinal medicine Ohshima clinic
Sapporo, Hokkaido, Japan
Oofuji Clinic
Amagasaki, Hyōgo, Japan
Mizutani Clinic
Kobe, Hyōgo, Japan
Nada Clinic
Kobe, Hyōgo, Japan
Idaimae-naika Clinic
Kawasaki, Kanagawa, Japan
Sakakibara Clinic, Wakaumekai Medical Corporation
Yokohama, Kanagawa, Japan
...and 10 more locations
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 4, 12, 24, and 52