NCT01107743

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,291 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Angina Pectoris
• Hypercholesterolemia
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Amlodipine/Atorvastatin	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-04-21
• Last updated: 2021-01-28
• Results posted: 2013-05-30