Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Amlodipine - reference, Amlodipine
Amlodipine- reference · 8 trials · 6 indications
Value at Week 8 minus value at baseline
Percent of "value at Week 8 minus value at baseline" over value at baseline
Mean change in the trough SBP
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
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
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
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).
Area under the concentration-time curve from zero time until the last sampling time
| Arm | Type | Description |
|---|---|---|
| CI-1038 2.5mg/5mg | ACTIVE_COMPARATOR | - |
| CI-1038 2.5mg/10mg | ACTIVE_COMPARATOR | - |
| CI-1038 5mg/5mg | ACTIVE_COMPARATOR | - |
| CI-1038 5mg/10mg | ACTIVE_COMPARATOR | - |
| Amlodipine 5mg | ACTIVE_COMPARATOR | - |
| Amlodipine 10mg | EXPERIMENTAL | - |
| Single | EXPERIMENTAL | - |
| treatment A - reference w/ water | ACTIVE_COMPARATOR | - |
| Treatment B - ODT (test) w/ water | EXPERIMENTAL | - |
| Treatment C - ODT (test) w/o water | EXPERIMENTAL | - |
| Treatment B - ODT (test) w/o water | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | 24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water. |
| Cohort 2 | ACTIVE_COMPARATOR | 24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water |
| Name | Type | Description |
|---|---|---|
| Amlodipine 2.5mg/Atorvastatin 5mg | DRUG | Single pill combination, dosed once daily for 8 weeks |
| Amlodipine 2.5mg/Atorvastatin 10mg | DRUG | Single pill combination, dosed once daily for 8 weeks |
| Amlodipine 5mg/Atorvastatin 5mg | DRUG | Single pill combination, dosed once daily for 8 weeks |
| Amlodipine 5mg/Atorvastatin 10mg | DRUG | Single pill combination, dosed once daily for 8 weeks |
| Amlodipine | DRUG | Amlodipine 5mg/ day |
| Amlodipine/Atorvastatin | DRUG | - |
| Amlodipine/atorvastatin single pill | DRUG | - |
| Amlodipine - reference | DRUG | 10 mg tablet, single dose, with water |
| Amlodipine ODT - test | DRUG | 10 mg orally disintegrating tablet (ODT), single dose, with water |
Inclusion Criteria: * The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female \>=20 to \<80 years of age at Visit 1. * The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP \>=140 mmHg and \<180 mmHg, * LDL-C \>=140 mg/dL and \<250 mg/dL at Vis...