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

NCT01107743 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1291

Last updated 2021-01-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-04-30
Completion
2012-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107743 on ClinicalTrials.gov