drugset / Trial / NCT00922480
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension Patients
Phase 3
Completed
506 enrolled
Boryung Pharmaceutical Co., Ltd
Ajou University · collabAsan Medical Center · collabCheil General Hospital and Women's Healthcare Center · collabChonbuk National University Hospital · collabChungbuk National University Hospital · collabChungnam National University · collabDongguk University International Hospital · collabHanyang University · collabInha University Hospital · collabKangbuk Samsung Hospital · collabKeimyung University · collabKonkuk University Medical Center · collabKonyang University Hospital · collabKorea University · collabKorea University Guro Hospital · collabSamsung Medical Center · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabSeverance Hospital · collabThe Catholic University of Korea · collabWonju Severance Christian Hospital · collabYeungnam University Hospital · collabYonsei University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg\~120 mg in patients with mild to moderate essential hypertension.
Timeline
- Start
- 2008-12
- Primary completion
- 2009-07
- Completion
- 2009-09
Publications
- Lee SE, Kim YJ, Lee HY, Yang HM, Park CG, Kim JJ, Kim SK, Rhee MY, Oh BH; Investigators. Efficacy and tolerability of fimasartan, a new angiotensin receptor blocker, compared with losartan (50/100 mg): a 12-week, phase III, multicenter, prospective, randomized, double-blind, parallel-group, dose escalation clinical trial with an optional 12-week extension phase in adult Korean patients with mild-to-moderate hypertension. Clin Ther. 2012 Mar;34(3):552-568, 568.e1-9. doi: 10.1016/j.clinthera.2012.01.024. Epub 2012 Mar 3.
- Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fimasartan | Small molecule | 60 mg | Oral |
| Comparator | Fimasartan | Small molecule | 120 mg | Oral |
| Comparator | Losartan | Other / unclassified | 50 mg | Oral |
| Comparator | Losartan | Other / unclassified | 100 mg | Oral |