Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,291
- 主要终点
- Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians
排除标准
- •Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.
研究组 & 干预措施
Amlodipine and Atorvastatin Combination Tablet
Subjects taking Amlodipine and Atorvastatin Combination Tablets
干预措施: Amlodipine/Atorvastatin (Drug)
结局指标
主要结局
Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- 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)