HypertensionENTER10NCT01252563

Amlodipine 10mg Drug Use Investigation

An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypertension
What is being tested?: Amlodipine
Type of treatment: Pill or oral medicine
How many people: 14,141 participants
Where: No sites listed yet
Study dates: Dec 2010to Oct 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The subjects who have been treated with amlodipine 5mg at least 4 weeks and had not achieved target BP.

Who may be able to join

Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
The subjects who had not achieved target BP

Who cannot join

Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before

About this study

Official title: 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.

Read the 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.

Conditions: Hypertension
Being tested: Amlodipine
Keywords: ENTER10, Hypertension, Japanese, Norvasc 10mg, Post Marketing surveillance
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmlodipineDrug
Also called Norvasc
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.

Study groups in NCT01252563
Study group	Role	What they receive
Amlodipine 10mg Tablet		Subjects taking Amlodipine 10mg Tablet. Receives: Drug: Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Secondary outcomes (16)

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).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Oct 2012

First posted3 Dec 2010 (estimated)
Study startDec 2010
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 14,141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01252563
Sponsor's protocol ID: A0531097
Acronym: ENTER10
Status last verified: Jan 2021
First submitted: 1 Dec 2010
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NORVASC10MG DRUG USE INVESTIGATION
ClinicalTrials.gov ID: NCT01252563
Acronym / sponsor ID: ENTER10 / A0531097
Conditions: Hypertension
Keywords: ENTER10, Hypertension, Japanese, Norvasc 10mg, Post Marketing surveillance
Study type: Observational
Recruitment status: Completed
Enrolment: 14,141 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2010 (actual)
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 2 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Amlodipine 10mg Tablet	–	Drug: AmlodipineSubjects taking Amlodipine 10mg Tablet.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The subjects who have been treated with amlodipine 5mg at least 4 weeks and had not achieved target BP.

Key inclusion criteria (2 listed)

Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
The subjects who had not achieved target BP

Key exclusion criteria (1 listed)

Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AmlodipineAlso: NorvascUsual 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.	Drug	Amlodipine 10mg Tablet

Primary outcome

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.

16 secondary outcomes

Number of Participants With Adverse Events Listed in Japanese Package Insert
Time frame: Last day of observation period (average of 14.76 weeks)
Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert
Time frame: Last day of observation period (average of 14.76 weeks)
Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
Time frame: Last day of observation period (average of 14.76 weeks)
Number of Participants With Treatment-Related Adverse Events: Male vs. Female
Time frame: Last day of observation period (average of 14.76 weeks)
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)
Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)
Time frame: Last day of observation period (average of 14.76 weeks)
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)
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)
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)
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)
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)
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)
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)
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)
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 Diastolic Blood Pressure From Baseline
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)

Results and safety

Results posted to the registry on 2 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine 10 mg Tablet	13,775	13,343

Primary outcome: Number of Participants With Treatment Related Adverse Events

Time frame: Last day of observation period (average of 14.76 weeks). Number. Unit: participants

Measure	Amlodipine 10 mg Tablet n = 13343
Value	208

Population analysed: The safety analysis population comprised participants who had taken Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day at least once after the start of treatment.

Primary outcome: 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). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	The Achievement Rate to Ambulatory Blood Pressure Goal n = 13124
Week 4	35.1 (34.2 to 36.1)
Week 8	40.1 (39.1 to 41.0)
Week 12	43.9 (42.8 to 44.9)
Last Day	43.9 (43.0 to 44.7)

Population analysed: The efficacy analysis population consisted of the participants, among the safety analysis population, who had their SBP/DBP measurement prior to the start of treatment and at least one post-baseline SBP/DBP measurement.

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	Changes in Ambulatory SBP From Baseline n = 13124
Week 4	-16.8 (15.20)
Week 8	-18.4 (15.90)
Week 12	-19.9 (16.05)
Last Day	-20.1 (16.31)

Changes in Ambulatory SBP From Baseline: p <0.001, t-test, 1 sided
Changes in Ambulatory SBP From Baseline: p <0.001, t-test, 1 sided
Changes in Ambulatory SBP From Baseline: p <0.001, t-test, 1 sided

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	Changes in Ambulatory DBP From Baseline n = 13124
Week 4	-8.2 (10.47)
Week 8	-9.1 (10.75)
Week 12	-9.9 (11.03)
Last Day	-10.0 (11.06)

Changes in Ambulatory DBP From Baseline: p <0.001, t-test, 1 sided
Changes in Ambulatory DBP From Baseline: p <0.001, t-test, 1 sided
Changes in Ambulatory DBP From Baseline: p <0.001, t-test, 1 sided

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine 10 mg Tablet	78 of 13,343 (0.6%)	250 of 13,343 (1.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Related Adverse Events (time frame: Last day of observation period (average of 14.76 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.