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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Angina Pectoris; Hypercholesterolemia; Familial Hypercholesterolemia

Intervention: Amlodipine/Atorvastatin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

The frequency of treatment related adverse events.

The proportion of responders to Amlodipine/Atorvastatin treatment.

Secondary outcome:

Teratment related unlisted adverse events in Japanese Package Insert.

Risk factors likely to affect the frequency of treatment related adverse events.

Risk factors likely to affect the proportion of responders.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or Female subjects intend to treat their cardiovascular disease who are

prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians

Exclusion Criteria:

Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2010
Last updated: April 20, 2010

Page last updated: October 04, 2010

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