N/A
Completed N=13,775
Amlodipine 10mg Drug Use Investigation
Source: ClinicalTrials.gov NCT01252563 ↗Enrolled (actual)
13,775
Serious AEs
0.6%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events — 208 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events |
208 | — |
| PRIMARY The Achievement Rate to Ambulatory Blood Pressure Goal |
35.1; 40.1; 43.9; 43.9 | — |
| PRIMARY Changes in Ambulatory Systolic Blood Pressure From Baseline |
-16.8; -18.4; -19.9; -20.1 | <0.001 sig |
| PRIMARY Changes in Ambulatory Diastolic Blood Pressure From Baseline |
-8.2; -9.1; -9.9; -10.0 | <0.001 sig |
| SECONDARY Number of Participants With Adverse Events Listed in Japanese Package Insert |
566 | — |
| SECONDARY Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert |
21 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s) |
170; 38 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: Male vs. Female |
87; 121 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris) |
21; 187 | 0.036 sig |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia) |
99; 109 | 0.020 sig |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive) |
136; 72 | 0.049 sig |
| SECONDARY Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB) |
118; 90 | 0.043 sig |
| SECONDARY Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus) |
52; 892 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease) |
24; 920 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction) |
1; 943 | 0.039 sig |
| SECONDARY Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome) |
92; 852 | <0.001 sig |
| SECONDARY Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure |
19; 171; 543; 182; 26 | <0.001 sig |
| SECONDARY The Achievement Rate to Home Blood Pressure Goal |
21.2; 27.9; 32.2; 31.3 | — |
| SECONDARY Changes in Home Systolic Blood Pressure From Baseline |
-15.7; -18.0; -19.9; -19.6 | <0.001 sig |
| SECONDARY Changes in Home Diastolic Blood Pressure From Baseline |
-8.3; -9.5; -10.4; -10.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
- The subjects who had not achieved target BP
Exclusion Criteria
- Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before
Data sourced from ClinicalTrials.gov (NCT01252563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.