Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine and Atorvastatin Combination Tablet | Subjects taking Amlodipine and Atorvastatin Combination Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine/Atorvastatin | Drug | 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
Not provided
Not provided
Not provided
Not provided
The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine and Atorvastatin Combination Tablet | Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine and Atorvastatin Combination Tablet | Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amlodipine and Atorvastatin Combination Tablet | Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA-J 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA-J 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000787 | Angina Pectoris |
| D006937 | Hypercholesterolemia |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487936 | amlodipine, atorvastatin drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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, "Classâ… , Classâ…¡, or Classâ…¢" is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension). | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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, "â… , â…¡a, â…¡b, â…¢, â…£, or â…¤" is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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, "Classâ… , Classâ…¡, or Classâ…¢" is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension). | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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, "â… , â…¡a, â…¡b, â…¢, â…£, or â…¤" 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Disease | Number | participants |
|
| Units | Counts |
|---|---|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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, "Classâ… , Classâ…¡, or Classâ…¢" is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension). | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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, "â… , â…¡a, â…¡b, â…¢, â…£, or â…¤" is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases. | The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed. | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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, "Classâ… , Classâ…¡, or Classâ…¢" is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension). | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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, "â… , â…¡a, â…¡b, â…¢, â…£, or â…¤" 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 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. | 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). | Posted | Number | participants | 8 weeks |
|
|
|
|
| 1 |
| 1,245 |
| 17 |
| 1,245 |
| Dizziness | Nervous system disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA-J 14.1 | Systematic Assessment |
|
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.
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |