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Amlodipine 10mg Drug Use Investigation (ENTER10)

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ClinicalTrials.gov Identifier: NCT01252563
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Hypertension 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.

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Study Type : Observational
Actual Enrollment : 14141 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: NORVASC10MG DRUG USE INVESTIGATION
Actual Study Start Date : December 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


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 Name: Norvasc




Primary Outcome Measures :
  1. 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.).

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 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).

  2. 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.).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252563


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01252563     History of Changes
Other Study ID Numbers: A0531097
First Posted: December 3, 2010    Key Record Dates
Results First Posted: April 2, 2019
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Pfizer:
ENTER10
Hypertension
Japanese
Norvasc 10mg
Post Marketing surveillance

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents