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

• ClinicalTrials.gov Identifier: NCT01107743
• Recruitment Status: Completed
• First Posted: April 21, 2010
• Results First Posted: May 30, 2013
• Last Update Posted: January 28, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

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.

Condition or disease	Intervention/treatment
Hypertension; Angina Pectoris; Hypercholesterolemia; Familial Hypercholesterolemia	Drug: Amlodipine/Atorvastatin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1291 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Caduet® Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
• Study Start Date: June 2010
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Groups and Cohorts

Group/Cohort

Intervention/treatment

Amlodipine and Atorvastatin Combination Tablet; Subjects taking Amlodipine and Atorvastatin Combination Tablets

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.; Other Name: Caduet

Outcome Measures

Primary Outcome Measures :

1. Number of Treatment Related Adverse Events. [ Time Frame: 8 weeks ]
   Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.
2. Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. [ Time Frame: 8 weeks ]
   The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.
3. Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. [ Time Frame: 8 weeks ]
   The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.
4. Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. [ Time Frame: 8 weeks ]
   The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.

Secondary Outcome Measures :

1. Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. [ Time Frame: 8 weeks ]
   Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
2. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.
3. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.
4. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.
5. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
6. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.
7. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.
8. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
9. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. [ Time Frame: 8 weeks ]
   Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.
10. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. [ Time Frame: 8 weeks ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.
11. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. [ Time Frame: 8 weeks ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.
12. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. [ Time Frame: 8 weeks ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.
13. Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. [ Time Frame: 8 weeks ]
    Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.
14. Risk Factors for the Proportion of Responders for Hypertension -Gender. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.
15. Risk Factors for the Proportion of Responders for Hypertension -Age. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.
16. Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, "ClassⅠ, ClassⅡ, or ClassⅢ" is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension).
17. Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.
18. Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.
19. Risk Factors for the Proportion of Responders for Hypertension -Complications. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.
20. Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.
21. Risk Factors for the Proportion of Responders for Angina Pectoris -Gender. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.
22. Risk Factors for the Proportion of Responders for Angina Pectoris -Age. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.
23. Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, "Class1, Class2, Class3, or Class4" is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina.
24. Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.
25. Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.
26. Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.
27. Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.
28. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
29. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
30. Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, "Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ" is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases.
31. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
32. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
33. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.
34. Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs. [ Time Frame: 8 weeks ]
    Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The subjects whom an investigator involving A3841063 prescribes the Amlodipine /Atorvastatin (Caduet®) Combination Tablets.

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.

Contacts and Locations

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01107743
• Other Study ID Numbers: A3841063
• First Posted: April 21, 2010
• Results First Posted: May 30, 2013
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

Hypertension; Angina pectoris; Hypercholesterolemia; Familial hypercholesterolemia; Japanese; caduet; Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:

Hypertension; Angina Pectoris; Hyperlipoproteinemia Type II; Hypercholesterolemia; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Hyperlipoproteinemias; Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Antihypertensive Agents