Amlodipine 10mg Drug Use Investigation

Completed

• Conditions: Hypertension
• Interventions: Drug: Amlodipine

• Registration Number: NCT01252563
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-03
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2014-11-13
• Results First Submitted QC: 2019-04-01
• Results First Posted: 2019-04-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amlodipine 10mg Tablet	Amlodipine	Subjects taking Amlodipine 10mg Tablet.

Primary Outcome Measures

Name	Time	Method
Changes in Ambulatory Systolic Blood Pressure From Baseline	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.
Changes in Ambulatory Diastolic Blood Pressure From Baseline	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.
The Achievement Rate to Ambulatory Blood Pressure Goal	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.
Number of Participants With Treatment Related Adverse Events	Last day of observation period (average of 14.76 weeks)	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.).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Listed in Japanese Package Insert	Last day of observation period (average of 14.76 weeks)	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).
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)	Last day of observation period (average of 14.76 weeks)	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.
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)	Last day of observation period (average of 14.76 weeks)	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.
Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)	Last day of observation period (average of 14.76 weeks)	To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Changes in Home Systolic Blood Pressure From Baseline	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.
Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)	Last day of observation period (average of 14.76 weeks)	To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)	Last day of observation period (average of 14.76 weeks)	To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert	Last day of observation period (average of 14.76 weeks)	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.).
Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)	Last day of observation period (average of 14.76 weeks)	To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)	Last day of observation period (average of 14.76 weeks)	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.
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)	Last day of observation period (average of 14.76 weeks)	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.
Changes in Home Diastolic Blood Pressure From Baseline	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.
Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)	Last day of observation period (average of 14.76 weeks)	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.
Number of Participants With Treatment-Related Adverse Events: Male vs. Female	Last day of observation period (average of 14.76 weeks)	To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure	Last day of observation period (average of 14.76 weeks)	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.
The Achievement Rate to Home Blood Pressure Goal	4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)	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.