Clinical trial NCT01107743: Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Angina Pectoris
Hypercholesterolemia
Familial Hypercholesterolemia
Keywords: Hypertension
Angina pectoris
Hypercholesterolemia
Familial hypercholesterolemia
Japanese
caduet
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 1291
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Number of Treatment Related Adverse Events.
timeFrame: 8 weeks
measure: Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.
timeFrame: 8 weeks
measure: Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.
timeFrame: 8 weeks
measure: Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.
timeFrame: 8 weeks
measure: Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Gender.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Age.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Complications.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Age.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.
timeFrame: 8 weeks
measure: Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.
timeFrame: 8 weeks
measure: Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: