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The objective of this study is to confirm the noninferiority of the blood pressure lowering effect of fimasartan and evaluate its safety compared to perindopril in the elderly with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan or Fimasartan/Hydrochlorothiazide | Experimental |
| |
| Perindopril or Perindopril/Indapamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan or Fimasartan/Hydrochlorothiazide | Drug | The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in siSBP | Change in siSBP from baseline after the administration of the investigational product for 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in siSBP | Change in siSBP from baseline at Weeks 4, 16 and 24 | Weeks 4, 16 and 24 |
| Change in siDBP | Change in siDBP from baseline at Weeks 4, 8, 16 and 24 |
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Inclusion Criteria:
Voluntarily provided a written consent to participate in this clinical study after receiving an explanation of this study
Elderly aged 70 years or older
At the screening visit (Visit 1), Blood pressure: Mean blood pressure measured 3 times on the selected arm is as below.
At the baseline visit (Visit 2), Blood pressure: Patients with mild to moderate essential hypertension whose mean siSBP measured 3 times on the selected arm is ≥140 mmHg Patients with treatment compliance of ≥70% during the placebo run-in period
Capable of understanding written instructions, cooperative, able to participate until the end of the clinical study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34503866 | Derived | Lee HY, Kim KI, Ihm SH, Rhee MY, Sohn IS, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. A Randomized, Double-blind, Active-controlled, Two Parallel-Group, Optional Titration, Multicenter, Phase IIIb Study to Evaluate the Efficacy and Safety of Fimasartan Versus Perindopril Monotherapy With and Without a Diuretic Combination in Elderly Patients With Essential Hypertension. Clin Ther. 2021 Oct;43(10):1746-1756. doi: 10.1016/j.clinthera.2021.08.003. Epub 2021 Sep 7. | |
| 31262348 |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D006852 | Hydrochlorothiazide |
| D020913 | Perindopril |
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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Parallel Assignment
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|
| Perindopril or Perindopril/Indapamide | Drug | The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product. |
|
| Weeks 4, 8, 16 and 24 |
| Blood pressure response rate | Blood pressure response rate (siSBP < 140 mmHg, or decrease of △siSBP ≥ 20 mmHg after the administration for 4, 8 and 16 weeks compared to baseline) and blood pressure normalization rate after the administration of the investigational products for 4, 8 and 16 weeks(siSBP<140mmHg and siDBP<90mmHg) | 4, 8 and 16 weeks |
| Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements | Change from baseline in the differences in standing SBP and DBP compared to their sitting measurements after the administration of the investigational product for 4, 8, 16 and 24 weeks | 4, 8, 16 and 24 weeks |
| Derived |
| Kang MG, Kim KI, Ihm SH, Rhee MY, Sohn IS, Lee HY, Park S, Jeon ES, Song JM, Pyun WB, Sung KC, Kim MH, Kim SH, Kim SY, Kim SJ, Kim EJ, Shin J, Lee SY, Chun KJ, Jeong JO, Chae SC, Yoo KD, Choi YJ, Park YH, Kim CH. Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial. Trials. 2019 Jul 1;20(1):389. doi: 10.1186/s13063-019-3466-5. |
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D000577 | Amides |