drugset / Trial / NCT02152306
Fimasartan/Amlodipine Combination Phase III
Phase 3
Completed
143 enrolled
Boryung Pharmaceutical Co., Ltd
Asan Medical Center · collabChonnam National University Hospital · collabChungnam National University · collabDong-A University Hospital · collabDongGuk University · collabGachon University Gil Medical Center · collabGangnam Severance Hospital · collabHanyang University Seoul Hospital · collabInje University · collabInje University Haeundae Paik Hospital · collabJeju National University Hospital · collabKangbuk Samsung Hospital · collabKeimyung University Dongsan Medical Center · collabKorea University Anam Hospital · collabKorea University Guro Hospital · collabKyungpook National University Hospital · collabPusan National University Hospital · collabPusan National University Yangsan Hospital · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabSeverance Hospital · collabThe Catholic University of Korea · collabUlsan University Hospital · collabWonju Severance Christian Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-03
- Completion
- 2015-07
Outcome
Met primary endpoint
paper 7.8 [13.3] mm Hg in the fimasartan group vs 20.5 [14.6] mm Hg in the fimasartan/amlodipine group; P < 0.0001). PMID 27502326 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 10 mg | — |
| Comparator | Fimasartan | Small molecule | 60 mg | — |