NCT Number: NCT01252563
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.).
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.
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.
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.
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).
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.).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
NORVASC10MG DRUG USE INVESTIGATION
Acronym: ENTER10
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05610059
Aging, Behavior
Tucson, Arizona, United States
View Trial DetailsNCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial DetailsNCT07735468
Behavior, Cardiovascular Diseases
Osuna, Sevilla, Spain
View Trial DetailsNCT00837122
Cardiovascular Diseases, Diabetes
Accra, Ghana
View Trial Details