Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia
This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.
This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HODO-2224-1+HODO-2224-2+HODO-2224-4 | Experimental | Oral tablet, QD |
|
| HODO-2224-1+HODO-2224-4+HODO-2224-5 | Active Comparator | Oral tablet, QD |
|
| HODO-2224-2+HODO-2224-3+HODO-2224-6 | Active Comparator | Oral tablet, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/Rosuvastatin/Candesartan/Amlodipine | Drug | PO, QD, 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224 | baseline and week 8 |
| Mean sitting systolic blood pressure (MSSBP) | MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224 | baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| change of other Lipid profile | change of other Lipid profile | 0, 4, 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Candesartan/Amlodipine |
| Drug |
PO, QD, 8 weeks |
|
| Candesartan/Rosuvastatin/Ezetimibe | Drug | PO, QD, 8 weeks |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| C081643 | candesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
Not provided
Not provided