Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)|
- The frequency of treatment related adverse events. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- The proportion of responders to Amlodipine/Atorvastatin treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Risk factors likely to affect the proportion of responders. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Amlodipine and Atorvastatin Combination Tablet
Subjects taking Amlodipine and Atorvastatin Combination Tablets
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.
Other Name: Caduet
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.