Amlodipine 10mg Drug Use Investigation

Overview

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.

Full Title of Study: “NORVASC10MG DRUG USE INVESTIGATION”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2012

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.

Interventions

  • Drug: Amlodipine
    • 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.

Arms, Groups and Cohorts

  • Amlodipine 10mg Tablet
    • Subjects taking Amlodipine 10mg Tablet.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Treatment Related Adverse Events
    • Time Frame: 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.).
  • The Achievement Rate to Ambulatory Blood Pressure Goal
    • Time Frame: 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.
  • Changes in Ambulatory Systolic Blood Pressure From Baseline
    • Time Frame: 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
    • Time Frame: 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.

Secondary Measures

  • Number of Participants With Adverse Events Listed in Japanese Package Insert
    • Time Frame: 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 Treatment Related Adverse Events Unlisted in Japanese Package Insert
    • Time Frame: 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 Complication(s)
    • Time Frame: 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
    • Time Frame: 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 With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)
    • Time Frame: 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)
    • Time Frame: 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 Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)
    • Time Frame: 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.
  • Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)
    • Time Frame: 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 (Diabetes Mellitus)
    • Time Frame: 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 (Chronic Kidney Disease)
    • Time Frame: 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)
    • Time Frame: 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.
  • Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)
    • Time Frame: 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 Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure
    • Time Frame: 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
    • Time Frame: 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.
  • Changes in Home Systolic Blood Pressure From Baseline
    • Time Frame: 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.
  • Changes in Home Diastolic Blood Pressure From Baseline
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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