N/A
N=1,291
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Hypertension · Angina Pectoris · Hypercholesterolemia · Familial Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01107743 ↗Enrolled (actual)
1,291
Serious AEs
0.1%
Results posted
May 2013
Primary outcome: Primary: Number of Treatment Related Adverse Events. — 18 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Amlodipine/Atorvastatin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Related Adverse Events. |
18 | — |
| PRIMARY Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. |
1151 | — |
| PRIMARY Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. |
163 | — |
| PRIMARY Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. |
1034 | — |
| SECONDARY Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. |
1; 1 | — |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. |
7; 11 | =0.812 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. |
5; 13 | =1.000 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. |
0; 18 | =1.000 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. |
5; 4; 3 | =0.112 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. |
18; 0 | =0.093 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. |
0; 18 | =1.000 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. |
0; 10; 2; 0; 0 | =0.839 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. |
18; 0 | =1.000 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. |
14; 2 | =1.000 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. |
14; 2 | =0.644 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. |
5; 13 | =0.155 |
| SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. |
3; 15 | =0.305 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Gender. |
415; 736 | =0.234 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Age. |
347; 804 | =0.439 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. |
615; 325; 85 | =0.761 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction. |
1008; 131 | =1.000 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction. |
1036; 102 | =0.310 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Complications. |
527; 624 | =0.251 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs. |
339; 812 | =0.756 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Gender. |
75; 88 | =0.706 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Age. |
45; 118 | =0.192 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity. |
122; 11; 2; 1 | =0.005 sig |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction. |
145; 18 | =1.000 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction. |
137; 25 | =0.596 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Complications. |
57; 106 | =0.252 |
| SECONDARY Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs. |
22; 141 | =1.000 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender. |
380; 654 | =0.518 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age. |
305; 729 | =0.645 |
| SECONDARY Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type. |
13; 533; 180; 10; 5 | =0.130 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction. |
904; 122 | =0.185 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction. |
937; 88 | =0.714 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications. |
482; 552 | =0.835 |
| SECONDARY Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs. |
306; 728 | =0.252 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01107743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.