Trial reportDrug design, development and therapy2026
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.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05878561 (A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg), which is not on this map. Not yet cited in PubMed.
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A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
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23 authors.
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Abstract
Purpose: Effective blood pressure (BP) control in hypertension frequently requires combination therapy, particularly in patients whose BP is inadequately controlled by monotherapy. This study evaluated the efficacy and safety of fimasartan (FMS) and indapamide (IND) sustained release (SR) combination therapy. Patients and Methods: In this randomized, double-blind, phase III trial, patients with hypertension who remained uncontrolled after a 4-week run-in with FMS 30 mg, were randomized to FMS 30 mg/IND SR 1.5 mg or FMS 30 mg, followed by forced titration to FMS 60 mg/IND SR 1.5 mg or FMS 60 mg after 4 weeks. The primary endpoint was the change in sitting systolic BP (SiSBP) at week 8. Secondary endpoints included changes in sitting diastolic BP (SiDBP), BP control rates, response rates, and safety outcomes. Results: Two hundred forty-eight patients were randomized (FMS/IND SR, n=126; FMS, n=122). At week 8, the least square mean reduction in SiSBP was greater with FMS/IND SR than with FMS (-17.9 vs -7.4 mmHg, Conclusion: FMS/IND SR combination therapy demonstrated superior antihypertensive efficacy, rapid BP control, and comparable safety to FMS monotherapy. This regimen may serve as an effective therapeutic option, particularly in elderly or high-risk hypertensive patients. Clinical Trial Registration: https://www.clinicaltrials.gov, NCT05878561.
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