Amlodipine 10mg Drug Use Investigation (ENTER10)

NORVASC10MG DRUG USE INVESTIGATION

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Amlodipine

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 Type: Observational
• Enrollment (Actual): 14141

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Amlodipine 10mg Tablet; Subjects taking Amlodipine 10mg Tablet.	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.; Other Names: Norvasc

What is the study measuring?

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)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Japanese; ENTER10; Norvasc 10mg; Post Marketing surveillance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: A0531097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.