Hypertension, Primary Hypercholesterolaemia
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGEzetimibe/Rosuvastatin/Candesartan/Amlodipine
PO, QD, 8 weeks
DRUGCandesartan/Amlodipine
PO, QD, 8 weeks
DRUGCandesartan/Rosuvastatin/Ezetimibe
PO, QD, 8 weeks
Sponsors
Hyundai Pharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 19 * Patients with Essential Hypertension and Primary Hypercholesterolemia
Exclusion criteria
* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP * Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low density lipoprotein cholesterol (LDL-C) | baseline and week 8 | LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224 |
| Mean sitting systolic blood pressure (MSSBP) | baseline and week 8 | MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of other Lipid profile | 0, 4, 8 weeks | change of other Lipid profile |
Countries
South Korea
Outcome results
None listed