Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,291
- Primary Endpoint
- Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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.
Arms & Interventions
Amlodipine and Atorvastatin Combination Tablet
Subjects taking Amlodipine and Atorvastatin Combination Tablets
Intervention: Amlodipine/Atorvastatin (Drug)
Outcomes
Primary Outcomes
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Number of Treatment Related Adverse Events.
Time Frame: 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.
Secondary Outcomes
- Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Gender.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Age.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.(8 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Complications.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Age.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.(8 weeks)
- Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.(8 weeks)
- Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.(8 weeks)
- Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.(8 weeks)