Trial Outcomes & Findings for Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient (NCT NCT00443456)
NCT ID: NCT00443456
Last Updated: 2009-10-28
Results Overview
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
134 participants
Primary outcome timeframe
Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
Results posted on
2009-10-28
Participant Flow
Among subjects who had completed the preceding study (A0531085, NCT00415623), where either Amlodipine 5 mg or 10 mg was administered for 8 weeks, those who were considered to be eligible for enrollment in this long-term study, based on safety and efficacy of the preceding study and who had a treatment compliance rate of at least 80% were enrolled.
Participant milestones
| Measure |
Amlodipine
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
|
|---|---|
|
Overall Study
STARTED
|
134
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Amlodipine
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Move
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Baseline characteristics by cohort
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
|
|---|---|
|
Age, Customized
20 to 44 years
|
13 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
65 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
56 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 0: Baseline (Actual Value)
|
148.8 mmHg
Standard Deviation 8.3
|
148.8 mmHg
Standard Deviation 8.0
|
148.8 mmHg
Standard Deviation 8.7
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 8
|
-8.7 mmHg
Standard Deviation 12.0
|
-5.6 mmHg
Standard Deviation 12.9
|
-12.0 mmHg
Standard Deviation 10.1
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 10
|
-14.8 mmHg
Standard Deviation 11.5
|
-14.5 mmHg
Standard Deviation 11.3
|
-15.0 mmHg
Standard Deviation 11.8
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 12
|
-15.6 mmHg
Standard Deviation 10.0
|
-15.6 mmHg
Standard Deviation 9.7
|
-15.7 mmHg
Standard Deviation 10.4
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 16
|
-16.7 mmHg
Standard Deviation 10.7
|
-16.9 mmHg
Standard Deviation 10.5
|
-16.4 mmHg
Standard Deviation 10.9
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 20
|
-15.8 mmHg
Standard Deviation 10.4
|
-17.4 mmHg
Standard Deviation 11.1
|
-14.1 mmHg
Standard Deviation 9.4
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 24
|
-15.4 mmHg
Standard Deviation 11.2
|
-16.1 mmHg
Standard Deviation 10.5
|
-14.6 mmHg
Standard Deviation 11.9
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 28
|
-14.7 mmHg
Standard Deviation 11.3
|
-15.7 mmHg
Standard Deviation 11.7
|
-13.6 mmHg
Standard Deviation 11.0
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 32
|
-13.8 mmHg
Standard Deviation 12.7
|
-14.4 mmHg
Standard Deviation 12.4
|
-13.2 mmHg
Standard Deviation 13.2
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 36
|
-13.4 mmHg
Standard Deviation 12.3
|
-14.6 mmHg
Standard Deviation 12.0
|
-12.2 mmHg
Standard Deviation 12.6
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 40
|
-13.9 mmHg
Standard Deviation 11.4
|
-14.7 mmHg
Standard Deviation 11.6
|
-13.0 mmHg
Standard Deviation 11.1
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 44
|
-15.7 mmHg
Standard Deviation 12.1
|
-15.6 mmHg
Standard Deviation 12.5
|
-15.8 mmHg
Standard Deviation 11.8
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 48
|
-15.3 mmHg
Standard Deviation 11.4
|
-16.0 mmHg
Standard Deviation 11.6
|
-14.5 mmHg
Standard Deviation 11.2
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Week 52
|
-15.6 mmHg
Standard Deviation 11.5
|
-15.0 mmHg
Standard Deviation 11.7
|
-16.3 mmHg
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 8: Baseline (Actual Value)
|
140.1 mmHg
Standard Deviation 14.2
|
143.2 mmHg
Standard Deviation 15.7
|
136.8 mmHg
Standard Deviation 11.6
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 10
|
-6.0 mmHg
Standard Deviation 10.9
|
-8.9 mmHg
Standard Deviation 11.2
|
-3.0 mmHg
Standard Deviation 9.8
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 12
|
-6.9 mmHg
Standard Deviation 11.9
|
-10.0 mmHg
Standard Deviation 13.6
|
-3.7 mmHg
Standard Deviation 8.8
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 16
|
-8.0 mmHg
Standard Deviation 12.0
|
-11.3 mmHg
Standard Deviation 13.3
|
-4.4 mmHg
Standard Deviation 9.4
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 20
|
-7.1 mmHg
Standard Deviation 12.0
|
-11.8 mmHg
Standard Deviation 12.7
|
-2.1 mmHg
Standard Deviation 9.0
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 24
|
-6.7 mmHg
Standard Deviation 12.4
|
-10.5 mmHg
Standard Deviation 12.7
|
-2.6 mmHg
Standard Deviation 10.8
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 28
|
-6.0 mmHg
Standard Deviation 13.0
|
-10.1 mmHg
Standard Deviation 13.9
|
-1.6 mmHg
Standard Deviation 10.3
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 32
|
-5.1 mmHg
Standard Deviation 12.2
|
-8.8 mmHg
Standard Deviation 13.0
|
-1.2 mmHg
Standard Deviation 9.9
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 36
|
-4.7 mmHg
Standard Deviation 12.6
|
-9.0 mmHg
Standard Deviation 13.2
|
-0.2 mmHg
Standard Deviation 10.4
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 40
|
-5.2 mmHg
Standard Deviation 13.7
|
-9.1 mmHg
Standard Deviation 14.9
|
-1.0 mmHg
Standard Deviation 10.9
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 44
|
-7.0 mmHg
Standard Deviation 12.6
|
-10.0 mmHg
Standard Deviation 14.1
|
-3.8 mmHg
Standard Deviation 10.0
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 48
|
-6.6 mmHg
Standard Deviation 13.4
|
-10.4 mmHg
Standard Deviation 14.4
|
-2.5 mmHg
Standard Deviation 10.9
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Week 52
|
-6.9 mmHg
Standard Deviation 13.0
|
-9.4 mmHg
Standard Deviation 14.0
|
-4.3 mmHg
Standard Deviation 11.4
|
PRIMARY outcome
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 0: Baseline (Actual Value)
|
86.3 mmHg
Standard Deviation 10.2
|
87.6 mmHg
Standard Deviation 10.0
|
84.8 mmHg
Standard Deviation 10.2
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 8
|
-3.1 mmHg
Standard Deviation 8.8
|
-1.8 mmHg
Standard Deviation 9.4
|
-4.5 mmHg
Standard Deviation 7.9
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 10
|
-6.4 mmHg
Standard Deviation 7.9
|
-6.6 mmHg
Standard Deviation 7.7
|
-6.3 mmHg
Standard Deviation 8.1
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 12
|
-6.9 mmHg
Standard Deviation 7.6
|
-7.7 mmHg
Standard Deviation 7.9
|
-6.0 mmHg
Standard Deviation 7.2
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 16
|
-7.3 mmHg
Standard Deviation 8.0
|
-8.4 mmHg
Standard Deviation 8.0
|
-6.2 mmHg
Standard Deviation 7.9
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 20
|
-7.2 mmHg
Standard Deviation 8.0
|
-7.9 mmHg
Standard Deviation 8.0
|
-6.4 mmHg
Standard Deviation 7.9
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 24
|
-6.8 mmHg
Standard Deviation 8.1
|
-7.1 mmHg
Standard Deviation 8.6
|
-6.5 mmHg
Standard Deviation 7.6
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 28
|
-6.8 mmHg
Standard Deviation 8.3
|
-7.8 mmHg
Standard Deviation 8.9
|
-5.7 mmHg
Standard Deviation 7.5
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 32
|
-6.8 mmHg
Standard Deviation 8.6
|
-7.1 mmHg
Standard Deviation 8.5
|
-6.5 mmHg
Standard Deviation 8.8
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 36
|
-6.5 mmHg
Standard Deviation 8.4
|
-7.4 mmHg
Standard Deviation 7.9
|
-5.5 mmHg
Standard Deviation 8.9
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 40
|
-6.8 mmHg
Standard Deviation 8.7
|
-7.2 mmHg
Standard Deviation 9.6
|
-6.3 mmHg
Standard Deviation 7.8
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 44
|
-7.3 mmHg
Standard Deviation 8.0
|
-7.6 mmHg
Standard Deviation 8.2
|
-6.9 mmHg
Standard Deviation 7.8
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 48
|
-7.2 mmHg
Standard Deviation 8.8
|
-7.3 mmHg
Standard Deviation 9.4
|
-7.0 mmHg
Standard Deviation 8.2
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Week 52
|
-7.9 mmHg
Standard Deviation 8.5
|
-8.2 mmHg
Standard Deviation 7.9
|
-7.7 mmHg
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 8: Baseline (Actual Value)
|
83.1 mmHg
Standard Deviation 11.5
|
85.8 mmHg
Standard Deviation 11.8
|
80.3 mmHg
Standard Deviation 10.5
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 10
|
-3.3 mmHg
Standard Deviation 7.2
|
-4.8 mmHg
Standard Deviation 7.5
|
-1.7 mmHg
Standard Deviation 6.6
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 12
|
-3.7 mmHg
Standard Deviation 7.3
|
-5.8 mmHg
Standard Deviation 8.1
|
-1.5 mmHg
Standard Deviation 5.6
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 16
|
-4.2 mmHg
Standard Deviation 7.9
|
-6.5 mmHg
Standard Deviation 8.3
|
-1.7 mmHg
Standard Deviation 6.6
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 20
|
-4.1 mmHg
Standard Deviation 7.5
|
-6.1 mmHg
Standard Deviation 8.3
|
-1.9 mmHg
Standard Deviation 5.8
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 24
|
-3.7 mmHg
Standard Deviation 8.4
|
-5.3 mmHg
Standard Deviation 8.4
|
-2.0 mmHg
Standard Deviation 8.2
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 28
|
-3.7 mmHg
Standard Deviation 8.3
|
-6.0 mmHg
Standard Deviation 8.8
|
-1.2 mmHg
Standard Deviation 6.9
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 32
|
-3.6 mmHg
Standard Deviation 8.4
|
-5.2 mmHg
Standard Deviation 8.3
|
-1.9 mmHg
Standard Deviation 8.3
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 36
|
-3.3 mmHg
Standard Deviation 9.2
|
-5.6 mmHg
Standard Deviation 9.1
|
-0.9 mmHg
Standard Deviation 8.7
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 40
|
-3.6 mmHg
Standard Deviation 9.1
|
-5.4 mmHg
Standard Deviation 9.8
|
-1.7 mmHg
Standard Deviation 8.0
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 44
|
-4.1 mmHg
Standard Deviation 8.3
|
-5.8 mmHg
Standard Deviation 8.7
|
-2.3 mmHg
Standard Deviation 7.4
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 48
|
-4.1 mmHg
Standard Deviation 8.7
|
-5.5 mmHg
Standard Deviation 9.5
|
-2.5 mmHg
Standard Deviation 7.6
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Week 52
|
-4.8 mmHg
Standard Deviation 9.6
|
-6.3 mmHg
Standard Deviation 9.5
|
-3.2 mmHg
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 8
|
41 participants
|
15 participants
|
26 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 10
|
59 participants
|
27 participants
|
32 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 12
|
64 participants
|
30 participants
|
34 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 16
|
62 participants
|
29 participants
|
33 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 20
|
65 participants
|
35 participants
|
30 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 24
|
64 participants
|
32 participants
|
32 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 28
|
54 participants
|
30 participants
|
24 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 32
|
53 participants
|
23 participants
|
30 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 36
|
56 participants
|
32 participants
|
24 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 40
|
56 participants
|
29 participants
|
27 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 44
|
58 participants
|
26 participants
|
32 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 48
|
58 participants
|
31 participants
|
27 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Week 52
|
63 participants
|
29 participants
|
34 participants
|
PRIMARY outcome
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Outcome measures
| Measure |
Amlodipine
n=134 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=69 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
n=65 Participants
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 8
|
36 participants
|
13 participants
|
23 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 10
|
55 participants
|
25 participants
|
30 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 12
|
60 participants
|
29 participants
|
31 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 24
|
60 participants
|
30 participants
|
30 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 28
|
54 participants
|
30 participants
|
24 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 40
|
52 participants
|
27 participants
|
25 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 16
|
59 participants
|
28 participants
|
31 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 20
|
62 participants
|
35 participants
|
27 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 32
|
50 participants
|
22 participants
|
28 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 36
|
54 participants
|
32 participants
|
22 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 44
|
57 participants
|
25 participants
|
32 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 48
|
56 participants
|
30 participants
|
26 participants
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
Week 52
|
60 participants
|
28 participants
|
32 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
-10.8 mmHg
Standard Deviation 8.5
|
-15.9 mmHg
Standard Deviation 11.0
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 0: Baseline (Actual Value)
|
153.9 mmHg
Standard Deviation 10.8
|
148.3 mmHg
Standard Deviation 7.9
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8 (n=13, 121)
|
-4.8 mmHg
Standard Deviation 8.1
|
-9.1 mmHg
Standard Deviation 12.3
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
-13.8 mmHg
Standard Deviation 8.7
|
-14.8 mmHg
Standard Deviation 11.8
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
-13.5 mmHg
Standard Deviation 8.0
|
-15.8 mmHg
Standard Deviation 9.9
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
-17.2 mmHg
Standard Deviation 8.9
|
-16.4 mmHg
Standard Deviation 10.5
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
-10.8 mmHg
Standard Deviation 6.0
|
-16.1 mmHg
Standard Deviation 10.3
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
-13.8 mmHg
Standard Deviation 14.0
|
-14.8 mmHg
Standard Deviation 10.2
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
-15.1 mmHg
Standard Deviation 10.9
|
-13.6 mmHg
Standard Deviation 10.4
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
-4.8 mmHg
Standard Deviation 13.9
|
-14.0 mmHg
Standard Deviation 11.7
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
-4.8 mmHg
Standard Deviation 13.2
|
-13.1 mmHg
Standard Deviation 11.5
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
-9.6 mmHg
Standard Deviation 8.3
|
-13.6 mmHg
Standard Deviation 10.9
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
-13.7 mmHg
Standard Deviation 8.3
|
-15.4 mmHg
Standard Deviation 12.0
|
—
|
|
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
-11.1 mmHg
Standard Deviation 12.5
|
-15.3 mmHg
Standard Deviation 10.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8: Baseline (Actual Value)
|
149.1 mmHg
Standard Deviation 15.1
|
139.2 mmHg
Standard Deviation 13.8
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
-9.0 mmHg
Standard Deviation 9.0
|
-5.9 mmHg
Standard Deviation 11.2
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
-8.4 mmHg
Standard Deviation 9.2
|
-6.9 mmHg
Standard Deviation 12.2
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
-12.0 mmHg
Standard Deviation 9.8
|
-7.6 mmHg
Standard Deviation 12.3
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
-5.6 mmHg
Standard Deviation 8.6
|
-7.3 mmHg
Standard Deviation 12.3
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
-9.9 mmHg
Standard Deviation 13.1
|
-5.0 mmHg
Standard Deviation 12.7
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
0.4 mmHg
Standard Deviation 17.5
|
-5.3 mmHg
Standard Deviation 11.5
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
0.2 mmHg
Standard Deviation 18.7
|
-4.5 mmHg
Standard Deviation 12.0
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
-4.5 mmHg
Standard Deviation 11.2
|
-5.2 mmHg
Standard Deviation 14.1
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
-9.1 mmHg
Standard Deviation 13.2
|
-7.1 mmHg
Standard Deviation 12.6
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
-7.3 mmHg
Standard Deviation 17.4
|
-7.0 mmHg
Standard Deviation 13.2
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
-7.1 mmHg
Standard Deviation 13.9
|
-7.5 mmHg
Standard Deviation 13.1
|
—
|
|
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
-9.2 mmHg
Standard Deviation 15.4
|
-6.2 mmHg
Standard Deviation 12.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 0: Baseline (Actual Value)
|
85.9 mmHg
Standard Deviation 12.4
|
86.3 mmHg
Standard Deviation 10.0
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8 (n=13, 121)
|
0.3 mmHg
Standard Deviation 9.9
|
-3.5 mmHg
Standard Deviation 8.6
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
-3.6 mmHg
Standard Deviation 9.1
|
-6.6 mmHg
Standard Deviation 7.7
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
-4.8 mmHg
Standard Deviation 9.7
|
-7.0 mmHg
Standard Deviation 7.4
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
-4.9 mmHg
Standard Deviation 9.2
|
-7.6 mmHg
Standard Deviation 8.0
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
-2.5 mmHg
Standard Deviation 9.3
|
-7.7 mmHg
Standard Deviation 7.9
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
-2.9 mmHg
Standard Deviation 10.3
|
-6.9 mmHg
Standard Deviation 8.1
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
-3.2 mmHg
Standard Deviation 7.5
|
-6.9 mmHg
Standard Deviation 8.6
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
1.7 mmHg
Standard Deviation 7.6
|
-7.4 mmHg
Standard Deviation 8.6
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
2.1 mmHg
Standard Deviation 8.6
|
-7.0 mmHg
Standard Deviation 8.2
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
0.8 mmHg
Standard Deviation 6.8
|
-7.3 mmHg
Standard Deviation 8.8
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
-2.4 mmHg
Standard Deviation 7.0
|
-7.5 mmHg
Standard Deviation 8.2
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
-0.8 mmHg
Standard Deviation 9.4
|
-7.5 mmHg
Standard Deviation 9.0
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
-2.7 mmHg
Standard Deviation 7.3
|
-8.4 mmHg
Standard Deviation 8.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8: Baseline (Actual Value)
|
86.2 mmHg
Standard Deviation 11.8
|
82.8 mmHg
Standard Deviation 11.4
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
-3.9 mmHg
Standard Deviation 5.4
|
-3.3 mmHg
Standard Deviation 7.5
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
-5.0 mmHg
Standard Deviation 4.9
|
-3.7 mmHg
Standard Deviation 7.6
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
-5.1 mmHg
Standard Deviation 5.0
|
-4.2 mmHg
Standard Deviation 8.2
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
-2.8 mmHg
Standard Deviation 6.4
|
-4.4 mmHg
Standard Deviation 7.7
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
-4.0 mmHg
Standard Deviation 8.4
|
-3.6 mmHg
Standard Deviation 8.7
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
-3.5 mmHg
Standard Deviation 8.6
|
-3.6 mmHg
Standard Deviation 8.4
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
1.5 mmHg
Standard Deviation 9.8
|
-4.2 mmHg
Standard Deviation 8.4
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
2.3 mmHg
Standard Deviation 11.8
|
-3.8 mmHg
Standard Deviation 9.2
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
0.6 mmHg
Standard Deviation 6.6
|
-4.1 mmHg
Standard Deviation 9.6
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
-3.4 mmHg
Standard Deviation 9.2
|
-4.4 mmHg
Standard Deviation 8.5
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
-1.9 mmHg
Standard Deviation 11.0
|
-4.6 mmHg
Standard Deviation 8.9
|
—
|
|
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
-3.8 mmHg
Standard Deviation 10.2
|
-5.4 mmHg
Standard Deviation 10.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
3 participants
|
59 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
2 participants
|
57 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
2 participants
|
46 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
2 participants
|
46 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
2 participants
|
45 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8 (n=13, 121)
|
2 participants
|
39 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
3 participants
|
54 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
4 participants
|
59 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
4 participants
|
56 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
1 participants
|
48 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
1 participants
|
49 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
1 participants
|
49 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
1 participants
|
54 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeksPopulation: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Outcome measures
| Measure |
Amlodipine
n=13 Participants
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
|
The Preceding Study 5 mg Sub-set of This Long-term Study
n=121 Participants
Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
|
The Preceding Study 10 mg Sub-set of This Long-term Study
Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
|
|---|---|---|---|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 10 (n=13, 118)
|
3 participants
|
50 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 20 (n=12, 116)
|
3 participants
|
56 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 24 (n=11, 113)
|
2 participants
|
53 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 28 (n=12, 111)
|
2 participants
|
46 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 32 (n=12, 111)
|
2 participants
|
43 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 36 (n=11, 108)
|
2 participants
|
43 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 40 (n=12, 108)
|
1 participants
|
44 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 44 (n=11, 108)
|
1 participants
|
48 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 48 (n=9, 107)
|
1 participants
|
47 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 52 (n=9, 106)
|
1 participants
|
51 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 8 (n=13, 121)
|
1 participants
|
35 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 12 (n=12, 119)
|
4 participants
|
55 participants
|
—
|
|
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Week 16 (n=12, 117)
|
4 participants
|
53 participants
|
—
|
Adverse Events
Amlodipine
Serious events: 8 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amlodipine
n=134 participants at risk
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
|
|---|---|
|
Cardiac disorders
Angina unstable
|
0.75%
1/134
|
|
Cardiac disorders
Atrioventricular block
|
0.75%
1/134
|
|
Cardiac disorders
Sick sinus syndrome
|
0.75%
1/134
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/134
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.75%
1/134
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.75%
1/134
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gum neoplasm malignant stage unspecified
|
0.75%
1/134
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.75%
1/134
|
|
Nervous system disorders
Cerebral infarction
|
0.75%
1/134
|
|
Nervous system disorders
Dizziness postural
|
0.75%
1/134
|
|
Nervous system disorders
Loss of consciousness
|
1.5%
2/134
|
Other adverse events
| Measure |
Amlodipine
n=134 participants at risk
All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
|
|---|---|
|
General disorders
Oedema peripheral
|
11.2%
15/134
|
|
Infections and infestations
Nasopharyngitis
|
24.6%
33/134
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
9/134
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER