Clinical trial NCT01252563: Amlodipine 10mg Drug Use Investigation
Official title: NORVASC10MG DRUG USE INVESTIGATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: ENTER10
Hypertension
Japanese
Norvasc 10mg
Post Marketing surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 14141
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who have been treated with amlodipine 5mg at least 4 weeks and had not achieved target BP.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: The Achievement Rate to Ambulatory Blood Pressure Goal
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
measure: Changes in Ambulatory Systolic Blood Pressure From Baseline
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
measure: Changes in Ambulatory Diastolic Blood Pressure From Baseline
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Secondary outcomes:
measure: Number of Participants With Adverse Events Listed in Japanese Package Insert
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: Male vs. Female
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure
timeFrame: Last day of observation period (average of 14.76 weeks)
measure: The Achievement Rate to Home Blood Pressure Goal
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
measure: Changes in Home Systolic Blood Pressure From Baseline
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
measure: Changes in Home Diastolic Blood Pressure From Baseline
timeFrame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: