Hypertension
Conditions
Keywords
ENTER10, Hypertension, Japanese, Norvasc 10mg, Post Marketing surveillance
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.
Interventions
DRUGAmlodipine
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Listed in Japanese Package Insert | 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 | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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. |
Participant flow
Pre-assignment details
A total of 14141 participants were registered in the study. Of the 14141 participants, 366 participants were excluded from the study because their case report forms were not collected, mainly due to the lack of cooperation from the investigators. Finally, 13775 participants were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine 10 mg Tablet Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert. | 13,343 |
| Total | 13,343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Centralized Registration Deviation | 30 |
| Overall Study | Contract Deviation | 41 |
| Overall Study | Lost to Follow-up | 161 |
| Overall Study | No drug administration | 6 |
| Overall Study | No visit after first day of treatment | 194 |
Baseline characteristics
| Characteristic | Amlodipine 10 mg Tablet |
|---|---|
| Age, Customized <65 years | 5229 Participants |
| Age, Customized >=65 years | 8114 Participants |
| Sex/Gender, Customized Female | 5839 Participants |
| Sex/Gender, Customized Male | 7504 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 250 / 13,343 |
| serious Total, serious adverse events | 78 / 13,343 |
Outcome results
Primary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine 10 mg Tablet | Changes in Ambulatory Diastolic Blood Pressure From Baseline | Week 4 | -8.2 mmHg | Standard Deviation 10.47 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Diastolic Blood Pressure From Baseline | Week 8 | -9.1 mmHg | Standard Deviation 10.75 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Diastolic Blood Pressure From Baseline | Week 12 | -9.9 mmHg | Standard Deviation 11.03 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Diastolic Blood Pressure From Baseline | Last Day | -10.0 mmHg | Standard Deviation 11.06 |
Comparison: The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Primary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine 10 mg Tablet | Changes in Ambulatory Systolic Blood Pressure From Baseline | Week 4 | -16.8 mmHg | Standard Deviation 15.2 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Systolic Blood Pressure From Baseline | Week 8 | -18.4 mmHg | Standard Deviation 15.9 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Systolic Blood Pressure From Baseline | Week 12 | -19.9 mmHg | Standard Deviation 16.05 |
| Amlodipine 10 mg Tablet | Changes in Ambulatory Systolic Blood Pressure From Baseline | Last Day | -20.1 mmHg | Standard Deviation 16.31 |
Comparison: The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Primary
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.).
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment Related Adverse Events | 208 participants |
Primary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine 10 mg Tablet | The Achievement Rate to Ambulatory Blood Pressure Goal | Week 4 | 35.1 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Ambulatory Blood Pressure Goal | Week 8 | 40.1 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Ambulatory Blood Pressure Goal | Week 12 | 43.9 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Ambulatory Blood Pressure Goal | Last Day | 43.9 Percentage of participants |
Secondary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine 10 mg Tablet | Changes in Home Diastolic Blood Pressure From Baseline | Week 4 | -8.3 mmHg | Standard Deviation 9.21 |
| Amlodipine 10 mg Tablet | Changes in Home Diastolic Blood Pressure From Baseline | Week 8 | -9.5 mmHg | Standard Deviation 9.46 |
| Amlodipine 10 mg Tablet | Changes in Home Diastolic Blood Pressure From Baseline | Week 12 | -10.4 mmHg | Standard Deviation 10.07 |
| Amlodipine 10 mg Tablet | Changes in Home Diastolic Blood Pressure From Baseline | Last Day | -10.4 mmHg | Standard Deviation 9.82 |
Comparison: The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.p-value: <0.001t-test, 1 sided
Secondary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine 10 mg Tablet | Changes in Home Systolic Blood Pressure From Baseline | Week 4 | -15.7 mmHg | Standard Deviation 13.34 |
| Amlodipine 10 mg Tablet | Changes in Home Systolic Blood Pressure From Baseline | Week 8 | -18.0 mmHg | Standard Deviation 13.8 |
| Amlodipine 10 mg Tablet | Changes in Home Systolic Blood Pressure From Baseline | Week 12 | -19.9 mmHg | Standard Deviation 14.38 |
| Amlodipine 10 mg Tablet | Changes in Home Systolic Blood Pressure From Baseline | Last Day | -19.6 mmHg | Standard Deviation 14.27 |
Comparison: The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Comparison: The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.p-value: <0.001t-test, 1 sided
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | 19 Participants |
| Without Complication(s) | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | 171 Participants |
| 140 to 160 mmHg at Baseline | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | 543 Participants |
| 160 to 180 mmHg at Baseline | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | 182 Participants |
| >= 180 mmHg at Baseline | Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure | 26 Participants |
Comparison: The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) | 24 Participants |
| Without Complication(s) | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) | 920 Participants |
Comparison: The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | 52 Participants |
| Without Complication(s) | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) | 892 Participants |
Comparison: The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) | 92 Participants |
| Without Complication(s) | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) | 852 Participants |
Comparison: The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) | 1 Participants |
| Without Complication(s) | Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) | 943 Participants |
Comparison: The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy.p-value: 0.039Chi-squared
Secondary
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).
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Adverse Events Listed in Japanese Package Insert | 566 participants |
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: Male vs. Female | 87 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: Male vs. Female | 121 Participants |
Comparison: The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) | 21 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) | 187 Participants |
Comparison: The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events.p-value: 0.036Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) | 99 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) | 109 Participants |
Comparison: The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events.p-value: 0.02Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | 170 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) | 38 Participants |
Comparison: The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events.p-value: <0.001Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) | 136 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) | 72 Participants |
Comparison: The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events.p-value: 0.049Chi-squared
Secondary
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.
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) | 118 Participants |
| Without Complication(s) | Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) | 90 Participants |
Comparison: The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events.p-value: 0.043Chi-squared
Secondary
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.).
Time frame: Last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine 10 mg Tablet | Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert | 21 Events |
Secondary
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.
Time frame: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine 10 mg Tablet | The Achievement Rate to Home Blood Pressure Goal | Week 4 | 21.2 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Home Blood Pressure Goal | Week 8 | 27.9 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Home Blood Pressure Goal | Week 12 | 32.2 Percentage of participants |
| Amlodipine 10 mg Tablet | The Achievement Rate to Home Blood Pressure Goal | Last Day | 31.3 Percentage of participants |