Trial Outcomes & Findings for Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01107743)
NCT ID: NCT01107743
Last Updated: 2021-01-28
Results Overview
Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.
COMPLETED
1291 participants
8 weeks
2021-01-28
Participant Flow
This was a phase 4, observational, open-label study conducted in Participants who were prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.
Participant milestones
| Measure |
Amlodipine and Atorvastatin Combination Tablet
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|
|
Overall Study
STARTED
|
1291
|
|
Overall Study
COMPLETED
|
1245
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
Amlodipine and Atorvastatin Combination Tablet
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|
|
Overall Study
Protocol Violation
|
46
|
Baseline Characteristics
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1245 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|
|
Age, Customized
<65 years
|
377 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
868 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
787 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
458 Participants
n=5 Participants
|
|
Type of Disease
Hypertension
|
1237 participants
n=5 Participants
|
|
Type of Disease
Angina pectoris
|
183 participants
n=5 Participants
|
|
Type of Disease
Hypercholesterolemia
|
1227 participants
n=5 Participants
|
|
Type of Disease
Familial hypercholesterolemia
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1245 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Related Adverse Events.
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1202 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
|
1151 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=170 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
|
163 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1057 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
|
1034 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1245 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
Anaemia
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
Hypoproteinaemia
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=458 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=787 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
|
7 participants
|
11 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 years is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=377 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=868 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
|
5 participants
|
13 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=8 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=1237 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
|
0 participants
|
18 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=656 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=351 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
n=95 Participants
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
|
5 participants
|
4 participants
|
3 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1062 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=183 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
|
18 participants
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=18 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=1227 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
|
0 participants
|
18 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=15 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=609 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
n=207 Participants
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
n=12 Participants
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
n=6 Participants
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
|
0 participants
|
10 participants
|
2 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1231 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=14 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
|
18 participants
|
0 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1087 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=145 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
|
14 participants
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1123 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=108 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
|
14 participants
|
2 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=568 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=677 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
|
5 participants
|
13 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=360 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=885 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
|
3 participants
|
15 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=438 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=764 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Gender.
|
415 participants
|
736 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=365 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=837 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Age.
|
347 participants
|
804 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=644 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=339 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
n=90 Participants
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
|
615 participants
|
325 participants
|
85 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1053 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=137 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
|
1008 participants
|
131 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1085 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=104 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
|
1036 participants
|
102 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=555 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=647 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Complications.
|
527 participants
|
624 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=355 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=847 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
|
339 participants
|
812 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=79 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=91 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
|
75 participants
|
88 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=45 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=125 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
|
45 participants
|
118 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, "Class1, Class2, Class3, or Class4" is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=125 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=14 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
n=2 Participants
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
n=2 Participants
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
|
122 participants
|
11 participants
|
2 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=152 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=18 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
|
145 participants
|
18 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=144 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=25 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
|
137 participants
|
25 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=61 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=109 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
|
57 participants
|
106 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=23 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=147 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
|
22 participants
|
141 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=390 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=667 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
|
380 participants
|
654 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=313 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=744 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
|
305 participants
|
729 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=13 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=541 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
n=187 Participants
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
n=11 Participants
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
n=5 Participants
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
|
13 participants
|
533 participants
|
180 participants
|
10 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=922 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=127 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
|
904 participants
|
122 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=959 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=89 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
|
937 participants
|
88 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=492 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=565 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
|
482 participants
|
552 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
Outcome measures
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=310 Participants
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Female
n=747 Participants
Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
ClassⅢ
Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅲ
Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅳ
Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
Type Ⅴ
Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|---|---|---|---|---|
|
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
|
306 participants
|
728 participants
|
—
|
—
|
—
|
—
|
Adverse Events
Amlodipine and Atorvastatin Combination Tablet
Serious adverse events
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1245 participants at risk
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Amlodipine and Atorvastatin Combination Tablet
n=1245 participants at risk
Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid oedema
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Flushing
|
0.16%
2/1245 • Number of events 2
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.16%
2/1245 • Number of events 2
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling abnormal
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.24%
3/1245 • Number of events 3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
0.08%
1/1245 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER