Trial Outcomes & Findings for Amlodipine 10mg Drug Use Investigation (NCT NCT01252563)
NCT ID: NCT01252563
Last Updated: 2021-01-28
Results Overview
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.).
Recruitment status
COMPLETED
Target enrollment
14141 participants
Primary outcome timeframe
Last day of observation period (average of 14.76 weeks)
Results posted on
2021-01-28
Participant Flow
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.
Participant milestones
| Measure |
Amlodipine 10 mg Tablet
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|
|
Overall Study
STARTED
|
13775
|
|
Overall Study
COMPLETED
|
13343
|
|
Overall Study
NOT COMPLETED
|
432
|
Reasons for withdrawal
| Measure |
Amlodipine 10 mg Tablet
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|
|
Overall Study
Contract Deviation
|
41
|
|
Overall Study
Centralized Registration Deviation
|
30
|
|
Overall Study
Lost to Follow-up
|
161
|
|
Overall Study
No visit after first day of treatment
|
194
|
|
Overall Study
No drug administration
|
6
|
Baseline Characteristics
Amlodipine 10mg Drug Use Investigation
Baseline characteristics by cohort
| Measure |
Amlodipine 10 mg Tablet
n=13343 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|
|
Age, Customized
<65 years
|
5229 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
8114 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
5839 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
7504 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.).
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13343 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Related Adverse Events
|
208 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
The Achievement Rate to Ambulatory Blood Pressure Goal
Week 4
|
35.1 Percentage of participants
Interval 34.2 to 36.1
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Ambulatory Blood Pressure Goal
Week 8
|
40.1 Percentage of participants
Interval 39.1 to 41.0
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Ambulatory Blood Pressure Goal
Week 12
|
43.9 Percentage of participants
Interval 42.8 to 44.9
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Ambulatory Blood Pressure Goal
Last Day
|
43.9 Percentage of participants
Interval 43.0 to 44.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Changes in Ambulatory Systolic Blood Pressure From Baseline
Week 4
|
-16.8 mmHg
Standard Deviation 15.20
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Systolic Blood Pressure From Baseline
Week 8
|
-18.4 mmHg
Standard Deviation 15.90
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Systolic Blood Pressure From Baseline
Week 12
|
-19.9 mmHg
Standard Deviation 16.05
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Systolic Blood Pressure From Baseline
Last Day
|
-20.1 mmHg
Standard Deviation 16.31
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Changes in Ambulatory Diastolic Blood Pressure From Baseline
Week 4
|
-8.2 mmHg
Standard Deviation 10.47
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Diastolic Blood Pressure From Baseline
Week 8
|
-9.1 mmHg
Standard Deviation 10.75
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Diastolic Blood Pressure From Baseline
Week 12
|
-9.9 mmHg
Standard Deviation 11.03
|
—
|
—
|
—
|
—
|
|
Changes in Ambulatory Diastolic Blood Pressure From Baseline
Last Day
|
-10.0 mmHg
Standard Deviation 11.06
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13343 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Listed in Japanese Package Insert
|
566 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.).
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13343 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert
|
21 Events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=9177 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=4166 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)
|
170 Participants
|
38 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
To determine whether gender was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=7504 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=5839 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: Male vs. Female
|
87 Participants
|
121 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
To determine whether having angina pectoris as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=872 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=12471 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)
|
21 Participants
|
187 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
To determine whether having dyslipidaemia as a complication was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=5308 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=8035 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)
|
99 Participants
|
109 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
To determine whether receiving antihypertensive as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=7834 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=5509 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)
|
136 Participants
|
72 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
To determine whether receiving ARB as a concomitant drug was a significant risk factor likely to affect the frequency of treatment-related adverse events.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=6641 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=6702 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)
|
118 Participants
|
90 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=2247 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=7004 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)
|
52 Participants
|
892 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=1034 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=8217 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)
|
24 Participants
|
920 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=55 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=9196 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)
|
1 Participants
|
943 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=1716 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=7535 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)
|
92 Participants
|
852 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=82 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
n=863 Participants
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
n=4675 Participants
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
n=2808 Participants
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
n=757 Participants
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure
|
19 Participants
|
171 Participants
|
543 Participants
|
182 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
The Achievement Rate to Home Blood Pressure Goal
Week 4
|
21.2 Percentage of participants
Interval 19.7 to 22.8
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Home Blood Pressure Goal
Week 8
|
27.9 Percentage of participants
Interval 26.2 to 29.6
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Home Blood Pressure Goal
Week 12
|
32.2 Percentage of participants
Interval 30.4 to 34.1
|
—
|
—
|
—
|
—
|
|
The Achievement Rate to Home Blood Pressure Goal
Last Day
|
31.3 Percentage of participants
Interval 29.9 to 32.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Changes in Home Systolic Blood Pressure From Baseline
Week 4
|
-15.7 mmHg
Standard Deviation 13.34
|
—
|
—
|
—
|
—
|
|
Changes in Home Systolic Blood Pressure From Baseline
Week 8
|
-18.0 mmHg
Standard Deviation 13.80
|
—
|
—
|
—
|
—
|
|
Changes in Home Systolic Blood Pressure From Baseline
Week 12
|
-19.9 mmHg
Standard Deviation 14.38
|
—
|
—
|
—
|
—
|
|
Changes in Home Systolic Blood Pressure From Baseline
Last Day
|
-19.6 mmHg
Standard Deviation 14.27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Amlodipine 10 mg Tablet
n=13124 Participants
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
Without Complication(s)
Participants who had no complication and experienced treatment-related adverse events after having received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert at least once.
|
140 to 160 mmHg at Baseline
Participants with ambulatory SBP of 140 to 160 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
160 to 180 mmHg at Baseline
Participants with ambulatory SBP of 160 to 180 mmHg at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
>= 180 mmHg at Baseline
Participants with ambulatory SBP of 180 mmHg or above at baseline who received Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|---|---|---|---|
|
Changes in Home Diastolic Blood Pressure From Baseline
Week 4
|
-8.3 mmHg
Standard Deviation 9.21
|
—
|
—
|
—
|
—
|
|
Changes in Home Diastolic Blood Pressure From Baseline
Week 8
|
-9.5 mmHg
Standard Deviation 9.46
|
—
|
—
|
—
|
—
|
|
Changes in Home Diastolic Blood Pressure From Baseline
Week 12
|
-10.4 mmHg
Standard Deviation 10.07
|
—
|
—
|
—
|
—
|
|
Changes in Home Diastolic Blood Pressure From Baseline
Last Day
|
-10.4 mmHg
Standard Deviation 9.82
|
—
|
—
|
—
|
—
|
Adverse Events
Amlodipine 10 mg Tablet
Serious events: 78 serious events
Other events: 250 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amlodipine 10 mg Tablet
n=13343 participants at risk
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|
|
Infections and infestations
Enteritis infectious
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Infections and infestations
Meningitis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Infections and infestations
Pneumonia
|
0.05%
7/13343 • Number of events 7
The frequency of adverse events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial haemangioma
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
7/13343 • Number of events 7
The frequency of adverse events during the study.
|
|
Nervous system disorders
Epilepsy
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.04%
6/13343 • Number of events 6
The frequency of adverse events during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.02%
3/13343 • Number of events 3
The frequency of adverse events during the study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.02%
3/13343 • Number of events 3
The frequency of adverse events during the study.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Nervous system disorders
Convulsion
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Prinzmetal angina
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Cardiac disorders
Cardiac failure acute
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Vascular disorders
Hypotension
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Aphagia
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Azotaemia
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Renal disorder
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.01%
2/13343 • Number of events 2
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
General disorders
Malaise
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
General disorders
Death
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
General disorders
Generalised oedema
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
General disorders
Oedema peripheral
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.01%
1/13343 • Number of events 1
The frequency of adverse events during the study.
|
Other adverse events
| Measure |
Amlodipine 10 mg Tablet
n=13343 participants at risk
Participants taking Amlodipine Tablets or Amlodipine OD Tablets 10 mg/day orally according to Japanese Package Insert.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.13%
17/13343 • Number of events 17
The frequency of adverse events during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
22/13343 • Number of events 22
The frequency of adverse events during the study.
|
|
Nervous system disorders
Headache
|
0.10%
14/13343 • Number of events 14
The frequency of adverse events during the study.
|
|
Nervous system disorders
Dizziness
|
0.34%
45/13343 • Number of events 45
The frequency of adverse events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.10%
14/13343 • Number of events 14
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
15/13343 • Number of events 15
The frequency of adverse events during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
16/13343 • Number of events 16
The frequency of adverse events during the study.
|
|
General disorders
Oedema
|
0.10%
14/13343 • Number of events 14
The frequency of adverse events during the study.
|
|
General disorders
Oedema peripheral
|
0.64%
85/13343 • Number of events 85
The frequency of adverse events during the study.
|
|
Investigations
Blood pressure decreased
|
0.17%
23/13343 • Number of events 23
The frequency of adverse events during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER