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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: Amlodipine/Atorvastatin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

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

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:

Number of Treatment Related Adverse Events.

Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.

Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.

Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.

Secondary outcome:

Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.

Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.

Risk Factors for the Proportion of Responders for Hypertension -Gender.

Risk Factors for the Proportion of Responders for Hypertension -Age.

Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.

Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.

Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.

Risk Factors for the Proportion of Responders for Hypertension -Complications.

Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.

Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.

Risk Factors for the Proportion of Responders for Angina Pectoris -Age.

Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.

Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.

Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.

Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.

Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.

Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.

Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.

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

Additional Information

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

Starting date: June 2010
Last updated: June 10, 2013

Page last updated: August 23, 2015

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