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
Not provided
The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan + Indapamide | Experimental | Treatment Period I, II |
|
| Fimasartan + Indapamide placebo | Active Comparator | Treatment Period I, II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan + Indapamide | Drug | a fixed dose combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sitting systolic blood pressure | The change of sitting systolic blood pressure | 8weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting systolic blood pressure | The change of sitting systolic blood pressure | 4weeks from Baseline Visit |
Not provided
Inclusion Criteria:
Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:
Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:
Voluntarily provided a written consent to participate in this clinical study
Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163997 | Derived | Youn JC, Lee SY, Yu CW, Sung KC, Shin J, Oh JH, Na JO, Kim DH, Cho EJ, Yoon HJ, Lee CJ, Lee HC, Lee HY, Sohn IS, Lee KS, Kim DI, Choi WG, Chung WJ, Lee EM, Choi SH, Choi S, Kang TS, Ihm SH. Efficacy and Safety of Fimasartan/Indapamide Combination Therapy versus Fimasartan Monotherapy in Patients with Essential Hypertension Inadequately Responding to Fimasartan 30 mg (FINEDUO): A Randomized, Double-Blind, Multicenter, Phase III Study. Drug Des Devel Ther. 2026 May 15;20:578736. doi: 10.2147/DDDT.S578736. eCollection 2026. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C558933 | fimasartan |
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fimasartan + Indapamide placebo | Drug | a fixed dose combination |
|
|
| Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |