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This is an 8-week, randomized, double-blind Phase 3, multicentre study to determine the optimal dose of AZM and AML in combination therapy and to compare efficacy and tolerability of the combined therapy to each of the monotherapy in essential hypertensive subjects who are not adequately controlled on AZM and AML monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZM Xmg | Active Comparator | 1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg (8 weeks) |
|
| AZM X'mg | Active Comparator | 1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg (8 weeks) |
|
| AML Ymg | Active Comparator | 1. AML Ymg (4 weeks) Non-responder -> AML Ymg (8 weeks) |
|
| AML Y'mg | Active Comparator | 1. AML Y'mg (4 weeks) Non-responder -> AML Y'mg (8 weeks) |
|
| AZM/AML X/Ymg | Active Comparator |
|
|
| AZM/AML X'/Ymg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZM X mg + AML Y mg | Drug | tablet, single dose, QD, oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| msitSBP | msitSBP change from baseline | after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| msitDBP | msitDBP change from baseline | after 8 weeks of treatment |
| msitSBP | msitSBP change from baseline | after 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celltrion | Incheon | South Korea |
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Single-blind Run-in period, Double-blind Treatment period
|
| AZM/AML X/Y'mg | Active Comparator |
|
|
| AZM/AML X'/Y'mg | Active Comparator |
|
|
| AZM X mg + AML Y' mg |
| Drug |
tablet, single dose, QD, oral administration |
|
| AZM X' mg + AML Y mg | Drug | tablet, single dose, QD, oral administration |
|
| AZM X' mg + AML Y' mg | Drug | tablet, single dose, QD, oral administration |
|
| AZM X mg | Drug | tablet, single dose, QD, oral administration |
|
| AZM X' mg | Drug | tablet, single dose, QD, oral administration |
|
| AML Y mg | Drug | tablet, single dose, QD, oral administration |
|
| AML Y' mg | Drug | tablet, single dose, QD, oral administration |
|
| msitDBP | msitDBP change from baseline | after 4 weeks of treatment |
| Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg | after 4, 8 weeks of treatment |
| Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg | after 4, 8 weeks of treatment |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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