Amlodipine 10mg Drug Use Investigation

Study Overview
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Brief Summary
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In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.

Detailed Description
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All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
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NORVASC10MG DRUG USE INVESTIGATION

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks The subjects who had not achieved target BP Exclusion Criteria: Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amlodipine 10mg Tablet<br>Subjects taking Amlodipine 10mg Tablet. | Drug: Amlodipine<br>* Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. Dosage should be adjusted depending on the patient's symptoms. The dose can be raised up to 10 mg once daily for patients who show inadequate response.<br>* Other names: Norvasc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | Last day of observation period (average of 14.76 weeks) | 
| The Achievement Rate to Ambulatory Blood Pressure Goal | The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 
| Changes in Ambulatory Systolic Blood Pressure From Baseline | Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 
| Changes in Ambulatory Diastolic Blood Pressure From Baseline | Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Listed in Japanese Package Insert | Adverse events refer to all events undesirable for participants that occur after the start of treatment with Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day, regardless of presence/absence of causal relationship with Amlodipine Tablets or Amlodipine OD Tablets (including clinically significant abnormal changes in laboratory test values). | Last day of observation period (average of 14.76 weeks) | 
| Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.). | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | To determine whether having complication(s) was a significant risk factor likely to affect the frequency of treatment-related adverse events. Complications included dyslipidemia, diabetes mellitus, metabolic syndrome, chronic kidney disease, angina pectoris, cerebrovascular disease, and myocardial infarction. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: Male vs. Female | To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) | To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) | To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) | To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) | To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | To determine whether having diabetes mellitus as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) | To determine whether having chronic kidney disease as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) | To determine whether having myocardial infarction as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) | To determine whether having metabolic syndrome as a complication was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) | 
| Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | To determine whether ambulatory systolic blood pressure at baseline was a significant risk factor likely to affect the efficacy. The achievement rates to the target blood pressure specified in the Japanese guidelines (JSH2009) were calculated on the last day of the observation period. | Last day of observation period (average of 14.76 weeks) | 
| The Achievement Rate to Home Blood Pressure Goal | The achievement rates to home blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 
| Changes in Home Systolic Blood Pressure From Baseline | Changes in home systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 
| Changes in Home Diastolic Blood Pressure From Baseline | Changes in home diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period. | 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ENTER10, Hypertension, Japanese, Norvasc 10mg, Post Marketing surveillance