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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

Tracking Information
First Submitted Date December 1, 2010
First Posted Date December 3, 2010
Results First Submitted Date November 13, 2014
Results First Posted Date April 2, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date December 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
  • 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.
Original Primary Outcome Measures
 (submitted: December 1, 2010)
  • The frequency of treatment related adverse events. [ Time Frame: 12 weeks ]
  • The achievement rate to Blood Pressure Goal. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01252563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 1, 2019)
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Amlodipine 10mg Drug Use Investigation
Official Title NORVASC10MG DRUG USE INVESTIGATION
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hypertension
Intervention 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
Study Groups/Cohorts Amlodipine 10mg Tablet
Subjects taking Amlodipine 10mg Tablet.
Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2014)
14141
Original Estimated Enrollment
 (submitted: December 1, 2010)
15000
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01252563
Other Study ID Numbers A0531097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019