Hypertension
Conditions
Brief summary
To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective (Protocol No.: A0531085).
Detailed description
NCT00415623 (protocol A0531085)
Interventions
DRUGAmlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety * Patients who had a treatment compliance rate of at least 80%
Exclusion criteria
* The patient who met the discontinuation criteria in the preceding study A0531085
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 |
| Change in Systolic Blood Pressure From Baseline of the Preceding Study | 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 | Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) |
| Change in Systolic Blood Pressure From Baseline of This Long-term Study | 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 weeks | Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) |
| Change in Diastolic Blood Pressure From Baseline of the Preceding Study | 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 | Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) |
| Change in Diastolic Blood Pressure From Baseline of This Long-term Study | 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 weeks | Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.) |
| Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent | 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 | Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) |
| Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent | 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 weeks | Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of 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, 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 | Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.) |
| Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent | 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 weeks | Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of 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 | 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 | 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 |
| 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 | 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 | 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 |
Countries
Japan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study. | 134 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Move | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Amlodipine |
|---|---|
| Age, Customized 20 to 44 years | 13 participants |
| Age, Customized 45 to 64 years | 65 participants |
| Age, Customized >=65 years | 56 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 134 |
| serious Total, serious adverse events | 8 / 134 |
Outcome results
Primary
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Time frame: 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
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -6.8 mmHg | Standard Deviation 8.6 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -7.3 mmHg | Standard Deviation 8 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -7.2 mmHg | Standard Deviation 8.8 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -6.8 mmHg | Standard Deviation 8.3 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -7.2 mmHg | Standard Deviation 8 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -3.1 mmHg | Standard Deviation 8.8 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -6.8 mmHg | Standard Deviation 8.1 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -7.3 mmHg | Standard Deviation 8 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -6.8 mmHg | Standard Deviation 8.7 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -6.4 mmHg | Standard Deviation 7.9 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 86.3 mmHg | Standard Deviation 10.2 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -6.5 mmHg | Standard Deviation 8.4 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -6.9 mmHg | Standard Deviation 7.6 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -7.9 mmHg | Standard Deviation 8.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -7.4 mmHg | Standard Deviation 7.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 87.6 mmHg | Standard Deviation 10 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -1.8 mmHg | Standard Deviation 9.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -6.6 mmHg | Standard Deviation 7.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -7.7 mmHg | Standard Deviation 7.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -8.4 mmHg | Standard Deviation 8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -7.9 mmHg | Standard Deviation 8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -7.1 mmHg | Standard Deviation 8.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -7.8 mmHg | Standard Deviation 8.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -7.1 mmHg | Standard Deviation 8.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -7.2 mmHg | Standard Deviation 9.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -7.6 mmHg | Standard Deviation 8.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -7.3 mmHg | Standard Deviation 9.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -8.2 mmHg | Standard Deviation 7.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -7.7 mmHg | Standard Deviation 9.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -6.5 mmHg | Standard Deviation 8.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -6.3 mmHg | Standard Deviation 8.1 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -7.0 mmHg | Standard Deviation 8.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -5.5 mmHg | Standard Deviation 8.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -4.5 mmHg | Standard Deviation 7.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -6.3 mmHg | Standard Deviation 7.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -6.4 mmHg | Standard Deviation 7.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -6.9 mmHg | Standard Deviation 7.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -6.5 mmHg | Standard Deviation 7.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -6.2 mmHg | Standard Deviation 7.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 84.8 mmHg | Standard Deviation 10.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -5.7 mmHg | Standard Deviation 7.5 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -6.0 mmHg | Standard Deviation 7.2 |
Primary
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Time frame: 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 weeks
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -4.1 mmHg | Standard Deviation 8.7 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -3.3 mmHg | Standard Deviation 9.2 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -3.7 mmHg | Standard Deviation 8.4 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -3.7 mmHg | Standard Deviation 7.3 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -3.6 mmHg | Standard Deviation 8.4 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -3.7 mmHg | Standard Deviation 8.3 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 83.1 mmHg | Standard Deviation 11.5 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -3.3 mmHg | Standard Deviation 7.2 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -4.1 mmHg | Standard Deviation 8.3 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -4.2 mmHg | Standard Deviation 7.9 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -4.8 mmHg | Standard Deviation 9.6 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -3.6 mmHg | Standard Deviation 9.1 |
| Amlodipine | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -4.1 mmHg | Standard Deviation 7.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -6.0 mmHg | Standard Deviation 8.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 85.8 mmHg | Standard Deviation 11.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -4.8 mmHg | Standard Deviation 7.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -5.8 mmHg | Standard Deviation 8.1 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -6.5 mmHg | Standard Deviation 8.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -6.1 mmHg | Standard Deviation 8.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -5.3 mmHg | Standard Deviation 8.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -5.2 mmHg | Standard Deviation 8.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -5.6 mmHg | Standard Deviation 9.1 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -5.4 mmHg | Standard Deviation 9.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -5.8 mmHg | Standard Deviation 8.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -5.5 mmHg | Standard Deviation 9.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -6.3 mmHg | Standard Deviation 9.5 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -0.9 mmHg | Standard Deviation 8.7 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -1.7 mmHg | Standard Deviation 6.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -2.5 mmHg | Standard Deviation 7.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -1.7 mmHg | Standard Deviation 8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -1.5 mmHg | Standard Deviation 5.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 80.3 mmHg | Standard Deviation 10.5 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -2.3 mmHg | Standard Deviation 7.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -1.2 mmHg | Standard Deviation 6.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -2.0 mmHg | Standard Deviation 8.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -1.7 mmHg | Standard Deviation 6.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -1.9 mmHg | Standard Deviation 8.3 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -1.9 mmHg | Standard Deviation 5.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Diastolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -3.2 mmHg | Standard Deviation 9.5 |
Primary
Change in Systolic Blood Pressure From Baseline of the Preceding Study
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Time frame: 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
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -15.6 mmHg | Standard Deviation 11.5 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -13.9 mmHg | Standard Deviation 11.4 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -15.8 mmHg | Standard Deviation 10.4 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -16.7 mmHg | Standard Deviation 10.7 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -14.8 mmHg | Standard Deviation 11.5 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -15.4 mmHg | Standard Deviation 11.2 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -15.6 mmHg | Standard Deviation 10 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -8.7 mmHg | Standard Deviation 12 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -13.4 mmHg | Standard Deviation 12.3 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -14.7 mmHg | Standard Deviation 11.3 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 148.8 mmHg | Standard Deviation 8.3 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -15.3 mmHg | Standard Deviation 11.4 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -15.7 mmHg | Standard Deviation 12.1 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -13.8 mmHg | Standard Deviation 12.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -14.4 mmHg | Standard Deviation 12.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 148.8 mmHg | Standard Deviation 8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -5.6 mmHg | Standard Deviation 12.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -16.1 mmHg | Standard Deviation 10.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -16.0 mmHg | Standard Deviation 11.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -15.0 mmHg | Standard Deviation 11.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -14.5 mmHg | Standard Deviation 11.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -15.6 mmHg | Standard Deviation 9.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -16.9 mmHg | Standard Deviation 10.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -17.4 mmHg | Standard Deviation 11.1 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -15.7 mmHg | Standard Deviation 11.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -14.6 mmHg | Standard Deviation 12 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -14.7 mmHg | Standard Deviation 11.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -15.6 mmHg | Standard Deviation 12.5 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 44 | -15.8 mmHg | Standard Deviation 11.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 40 | -13.0 mmHg | Standard Deviation 11.1 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 28 | -13.6 mmHg | Standard Deviation 11 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 48 | -14.5 mmHg | Standard Deviation 11.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 32 | -13.2 mmHg | Standard Deviation 13.2 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 24 | -14.6 mmHg | Standard Deviation 11.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 0: Baseline (Actual Value) | 148.8 mmHg | Standard Deviation 8.7 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 10 | -15.0 mmHg | Standard Deviation 11.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 36 | -12.2 mmHg | Standard Deviation 12.6 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 12 | -15.7 mmHg | Standard Deviation 10.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 8 | -12.0 mmHg | Standard Deviation 10.1 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 20 | -14.1 mmHg | Standard Deviation 9.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 16 | -16.4 mmHg | Standard Deviation 10.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of the Preceding Study | Week 52 | -16.3 mmHg | Standard Deviation 11.3 |
Primary
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Time frame: 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 weeks
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -5.2 mmHg | Standard Deviation 13.7 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -6.7 mmHg | Standard Deviation 12.4 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -6.0 mmHg | Standard Deviation 13 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -5.1 mmHg | Standard Deviation 12.2 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -7.0 mmHg | Standard Deviation 12.6 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -6.9 mmHg | Standard Deviation 13 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -6.0 mmHg | Standard Deviation 10.9 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -6.6 mmHg | Standard Deviation 13.4 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 140.1 mmHg | Standard Deviation 14.2 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -4.7 mmHg | Standard Deviation 12.6 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -6.9 mmHg | Standard Deviation 11.9 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -8.0 mmHg | Standard Deviation 12 |
| Amlodipine | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -7.1 mmHg | Standard Deviation 12 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -10.0 mmHg | Standard Deviation 13.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -9.0 mmHg | Standard Deviation 13.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -10.5 mmHg | Standard Deviation 12.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -9.1 mmHg | Standard Deviation 14.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -11.8 mmHg | Standard Deviation 12.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -10.1 mmHg | Standard Deviation 13.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -8.8 mmHg | Standard Deviation 13 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 143.2 mmHg | Standard Deviation 15.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -10.4 mmHg | Standard Deviation 14.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -11.3 mmHg | Standard Deviation 13.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -8.9 mmHg | Standard Deviation 11.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -9.4 mmHg | Standard Deviation 14 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -10.0 mmHg | Standard Deviation 14.1 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 52 | -4.3 mmHg | Standard Deviation 11.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 32 | -1.2 mmHg | Standard Deviation 9.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 36 | -0.2 mmHg | Standard Deviation 10.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 40 | -1.0 mmHg | Standard Deviation 10.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 44 | -3.8 mmHg | Standard Deviation 10 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 10 | -3.0 mmHg | Standard Deviation 9.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 12 | -3.7 mmHg | Standard Deviation 8.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 16 | -4.4 mmHg | Standard Deviation 9.4 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 20 | -2.1 mmHg | Standard Deviation 9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 24 | -2.6 mmHg | Standard Deviation 10.8 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 28 | -1.6 mmHg | Standard Deviation 10.3 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 48 | -2.5 mmHg | Standard Deviation 10.9 |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Change in Systolic Blood Pressure From Baseline of This Long-term Study | Week 8: Baseline (Actual Value) | 136.8 mmHg | Standard Deviation 11.6 |
Primary
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
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
Time frame: 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
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 8 | 41 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 32 | 53 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 48 | 58 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 10 | 59 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 12 | 64 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 16 | 62 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 20 | 65 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 24 | 64 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 28 | 54 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 36 | 56 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 40 | 56 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 44 | 58 participants |
| Amlodipine | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 52 | 63 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 44 | 26 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 8 | 15 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 36 | 32 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 32 | 23 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 24 | 32 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 52 | 29 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 48 | 31 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 28 | 30 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 10 | 27 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 20 | 35 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 40 | 29 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 12 | 30 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 16 | 29 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 12 | 34 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 16 | 33 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 20 | 30 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 24 | 32 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 28 | 24 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 32 | 30 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 48 | 27 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 44 | 32 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 36 | 24 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 8 | 26 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 52 | 34 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 10 | 32 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value | Week 40 | 27 participants |
Primary
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
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
Time frame: 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
Population: Full Analysis Set, Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 30 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 13 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 28 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 25 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 30 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 22 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 30 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 29 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 32 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 35 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 27 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 25 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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 | 28 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 26 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 31 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 31 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 27 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 24 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 28 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 22 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 25 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 32 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 32 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 23 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 30 participants |
| The Preceding Study 10 mg Sub-set of This Long-term Study | 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 | 30 participants |
Other Pre-specified
Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Time frame: 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
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.3 mmHg | Standard Deviation 8.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 86.3 mmHg | Standard Deviation 10 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -6.9 mmHg | Standard Deviation 8.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.5 mmHg | Standard Deviation 8.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.5 mmHg | Standard Deviation 9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -6.6 mmHg | Standard Deviation 7.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.4 mmHg | Standard Deviation 8.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.0 mmHg | Standard Deviation 7.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.5 mmHg | Standard Deviation 8.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.6 mmHg | Standard Deviation 8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.0 mmHg | Standard Deviation 8.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.7 mmHg | Standard Deviation 7.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -8.4 mmHg | Standard Deviation 8.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -6.9 mmHg | Standard Deviation 8.1 |
Other Pre-specified
Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Time frame: 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 weeks
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.2 mmHg | Standard Deviation 8.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 82.8 mmHg | Standard Deviation 11.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.3 mmHg | Standard Deviation 7.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.7 mmHg | Standard Deviation 7.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.2 mmHg | Standard Deviation 8.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.4 mmHg | Standard Deviation 7.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.6 mmHg | Standard Deviation 8.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.6 mmHg | Standard Deviation 8.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -3.8 mmHg | Standard Deviation 9.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.1 mmHg | Standard Deviation 9.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.4 mmHg | Standard Deviation 8.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.6 mmHg | Standard Deviation 8.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -5.4 mmHg | Standard Deviation 10.1 |
Other Pre-specified
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Time frame: 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
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -15.9 mmHg | Standard Deviation 11 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -16.4 mmHg | Standard Deviation 10.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -16.1 mmHg | Standard Deviation 10.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -14.8 mmHg | Standard Deviation 10.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 148.3 mmHg | Standard Deviation 7.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -9.1 mmHg | Standard Deviation 12.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -14.8 mmHg | Standard Deviation 11.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -13.6 mmHg | Standard Deviation 10.4 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -14.0 mmHg | Standard Deviation 11.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -13.1 mmHg | Standard Deviation 11.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -13.6 mmHg | Standard Deviation 10.9 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -15.4 mmHg | Standard Deviation 12 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -15.3 mmHg | Standard Deviation 10.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -15.8 mmHg | Standard Deviation 9.9 |
Other Pre-specified
Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Time frame: 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 weeks
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -5.2 mmHg | Standard Deviation 14.1 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -5.0 mmHg | Standard Deviation 12.7 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 139.2 mmHg | Standard Deviation 13.8 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.0 mmHg | Standard Deviation 13.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -5.9 mmHg | Standard Deviation 11.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -5.3 mmHg | Standard Deviation 11.5 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -6.9 mmHg | Standard Deviation 12.2 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.1 mmHg | Standard Deviation 12.6 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.6 mmHg | Standard Deviation 12.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -4.5 mmHg | Standard Deviation 12 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.3 mmHg | Standard Deviation 12.3 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -7.5 mmHg | Standard Deviation 13.1 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | -6.2 mmHg | Standard Deviation 12.1 |
Other Pre-specified
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
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
Time frame: 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
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 56 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 35 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 43 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 50 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 51 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 55 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 44 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 53 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 53 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 48 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 46 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 47 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 43 participants |
Other Pre-specified
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent
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
Time frame: 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
Population: Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| Amlodipine | 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 |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 59 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 39 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 54 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 56 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 46 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 59 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 54 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 57 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 46 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 45 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 48 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 49 participants |
| The Preceding Study 5 mg Sub-set of This Long-term Study | 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) | 49 participants |