At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
In Brief
An observational study evaluating Amlodipine/Atorvastatin for Hypertension and 3 related conditions. Completed, enrolled 1,291 participants.
Detailed 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.
Study Details
Timeline
Interventions
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.