Angina Pectoris, Familial Hypercholesterolemia, Hypercholesterolemia, Hypertension
Conditions
Keywords
Hypertension, Angina pectoris, Hypercholesterolemia, Familial hypercholesterolemia, Japanese, caduet, Regulatory Post Marketing Commitment Plan
Brief summary
In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet® Combination Tablets) in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
Detailed description
All the subjects whom an investigator prescribes the first Amlodipine /Atorvastatin (Caduet®) Combination Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
Amlodipine and Atorvastatin combination Tablet is indicated in following subjects for whom treatment with both amlodipine and atorvastatin is appropriate. Subjects with concurrent hypertension or angina pectoris and hypercholesterolemia or familial hypercholesterolemia Indications for amlodipine and atorvastatin. For oral use, amlodipine and atorvastatin combination tablet is given once daily. Dosage must be individualized based on dosage and administration for each individual component. Amlodipine * Hypertension Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. * Angina pectoris For oral use, the usual adult dosage is 5 mg of amlodipine once daily. Atorvastatin * Hypercholesterolemia For oral use, the usual adult dosage is 10-20 mg of atorvastatin once daily. * Familial hypercholesterolemia For oral use, the usual adult dosage is 10-40 mg of atorvastatin once daily.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians
Exclusion criteria
Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Related Adverse Events. | 8 weeks | 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. |
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | 8 weeks | 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. |
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | 8 weeks | 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. |
| Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 8 weeks | 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). |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. | 8 weeks | Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor. |
| Risk Factors for the Proportion of Responders for Hypertension -Gender. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension. |
| Risk Factors for the Proportion of Responders for Hypertension -Age. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Hypertension. |
| Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. | 8 weeks | 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). |
| Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension. |
| Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension. |
| Risk Factors for the Proportion of Responders for Hypertension -Complications. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension. |
| Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Gender. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Age. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Angina Pectoris. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. | 8 weeks | 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. |
| Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs. | 8 weeks | 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. |
| Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 8 weeks | Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 8 weeks | 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. |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 8 weeks | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine and Atorvastatin Combination Tablet Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. | 1,245 |
| Total | 1,245 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 46 |
Baseline characteristics
| Characteristic | Amlodipine and Atorvastatin Combination Tablet |
|---|---|
| Age, Customized <65 years | 377 participants |
| Age, Customized >=65 years | 868 participants |
| Sex: Female, Male Female | 787 Participants |
| Sex: Female, Male Male | 458 Participants |
| Type of Disease Angina pectoris | 183 participants |
| Type of Disease Familial hypercholesterolemia | 14 participants |
| Type of Disease Hypercholesterolemia | 1227 participants |
| Type of Disease Hypertension | 1237 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 1,245 |
| serious Total, serious adverse events | 1 / 1,245 |
Outcome results
Primary
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | 163 participants |
Primary
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | 1034 participants |
Primary
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | 1151 participants |
Primary
Number of Treatment Related Adverse Events.
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.
Time frame: 8 weeks
Population: The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Number of Treatment Related Adverse Events. | 18 participants |
Secondary
Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | Anaemia | 1 participants |
| Amlodipine and Atorvastatin Combination Tablet | Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | Hypoproteinaemia | 1 participants |
Secondary
Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 13 participants |
| Female | Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 533 participants |
| ClassⅢ | Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 180 participants |
| Type Ⅲ | Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 10 participants |
| Type Ⅳ | Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. | 5 participants |
Comparison: The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders.p-value: =0.13Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 5 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 13 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 18 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 0 participants |
Comparison: The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.093Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. | 5 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. | 13 participants |
Comparison: The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.155Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. | 3 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. | 15 participants |
Comparison: The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.305Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. | 18 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. | 0 participants |
Comparison: The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 7 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 11 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.812Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. | 14 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. | 2 participants |
Comparison: The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. | 0 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. | 18 participants |
Comparison: The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 0 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 10 participants |
| ClassⅢ | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 2 participants |
| Type Ⅲ | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 0 participants |
| Type Ⅳ | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 0 participants |
Comparison: The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.839Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 0 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 18 participants |
Comparison: The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =1Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
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).
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 5 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 4 participants |
| ClassⅢ | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 3 participants |
Comparison: The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.112Fisher Exact
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
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.
Time frame: 8 weeks
Population: The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. | 14 participants |
| Female | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. | 2 participants |
Comparison: The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs).p-value: =0.644Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Angina Pectoris.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Age. | 45 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Age. | 118 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders.p-value: =0.192Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. | 122 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. | 11 participants |
| ClassⅢ | Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. | 2 participants |
| Type Ⅲ | Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. | 1 participants |
Comparison: The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders.p-value: =0.005Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. | 57 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. | 106 participants |
Comparison: The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders.p-value: =0.252Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. | 22 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. | 141 participants |
Comparison: The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Gender. | 75 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Gender. | 88 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders.p-value: =0.706Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction. | 145 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction. | 18 participants |
Comparison: The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. | 137 participants |
| Female | Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. | 25 participants |
Comparison: The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders.p-value: =0.596Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. | 305 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. | 729 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders.p-value: =0.645Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. | 482 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. | 552 participants |
Comparison: The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders.p-value: =0.835Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs. | 306 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs. | 728 participants |
Comparison: The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders.p-value: =0.252Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender. | 380 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender. | 654 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders.p-value: =0.518Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. | 904 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. | 122 participants |
Comparison: The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders.p-value: =0.185Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
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.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction. | 937 participants |
| Female | Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction. | 88 participants |
Comparison: The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders.p-value: =0.714Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Age.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether \<65 years or \>=65 is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Age. | 347 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Age. | 804 participants |
Comparison: The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders.p-value: =0.439Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Complications.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Complications. | 527 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Complications. | 624 participants |
Comparison: The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders.p-value: =0.251Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs. | 339 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs. | 812 participants |
Comparison: The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders.p-value: =0.756Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Gender.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Gender. | 415 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Gender. | 736 participants |
Comparison: The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders.p-value: =0.234Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction. | 1008 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction. | 131 participants |
Comparison: The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders.p-value: =1Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
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).
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. | 615 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. | 325 participants |
| ClassⅢ | Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. | 85 participants |
Comparison: The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders.p-value: =0.761Fisher Exact
Secondary
Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.
Time frame: 8 weeks
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction. | 1036 participants |
| Female | Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction. | 102 participants |
Comparison: The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders.p-value: =0.31Fisher Exact