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NCT03246555: FITNESS
Fimasartan in the Senior Subjects
Phase 3 trial testing Fimasartan or Fimasartan/Hydrochlorothiazide in The Elderly (≥ 70 Years) With Essential Hypertension in 241 participants. Completed in 9 December 2019.
19 August 2019
Quick facts
| Lead sponsor | Boryung Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 241 |
| Start date | 15 July 2016 |
| Primary completion | 19 August 2019 |
| Estimated completion | 9 December 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Fimasartan or Fimasartan/Hydrochlorothiazide — full drug profile →
- Perindopril or Perindopril/Indapamide — full drug profile →
Conditions studied
- The Elderly (≥ 70 Years) With Essential Hypertension — all drugs for The Elderly (≥ 70 Years) With Essential Hypertension →
Sponsor
Boryung Pharmaceutical Co., Ltd — full company profile →
Who can join
70 and older, any sex, with The Elderly (≥ 70 Years) With Essential Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Kang MG, Kim KI, Ihm SH, Rhee MY, et al · · 2019 · cited 3× · PMID 31262348 · DOI 10.1186/s13063-019-3466-5 -
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 Hyperte
Lee HY, Kim KI, Ihm SH, Rhee MY, et al · · 2021 · cited 1× · PMID 34503866 · DOI 10.1016/j.clinthera.2021.08.003
Verify or expand the search:
- PubMed search for NCT03246555
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Boryung Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07421414 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421401 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421388 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421375 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07373613 — A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03246555 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boryung Pharmaceutical Co., Ltd
- Last refreshed: 23 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03246555.
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