Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Angina Pectoris Hypercholesterolemia Familial Hypercholesterolemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Amlodipine and Atorvastatin Combination Tablet

Subjects taking Amlodipine and Atorvastatin Combination Tablets

Amlodipine/Atorvastatin

Intervention Type 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

* 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.

Interventions

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