| Trial ID: | L5869 |
| Source ID: | NCT06220773
|
| Associated Drug: |
Br1019a
|
| Title: |
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Essential Hypertension|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: BR1019A|DRUG: BR1019B|DRUG: BR1019C|DRUG: BR1019A-1|DRUG: BR1019B-1|DRUG: BR1019C-1
|
| Outcome Measures: |
Primary: The change of mean sitting systolic blood pressure from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A-1+BR1019B+BR1019C-1, 12 weeks from Baseline Visit|The change of HbA1c from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A+BR1019B-1+BR1019C-1, 12 weeks from Baseline Visit |
|
| Sponsor/Collaborators: |
Sponsor: Boryung Pharmaceutical Co., Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
276
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05-21
|
| Completion Date: |
2025-04
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-22
|
| Locations: |
Severance Hospital, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06220773
|
