Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Trial · NCT01107743
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Related Adverse Events. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris. | 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. |
| Primary | Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia. | 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 | Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity. | 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). |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications. | 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. |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs. | 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. |
| Secondary | Risk Factors for the Proportion of Responders for Hypertension -Gender. | 8 weeks | Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension. |
| Secondary | Risk Factors for the Proportion of Responders for Hypertension -Age. | 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. |
| Secondary | Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity. | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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