Clinical Trial to Evaluate the Efficacy and Safety of OLOMAX Tab

NCT04120753 ↗

Phase 4 Completed 106 enrolled Daewoong Pharmaceutical Co. LTD.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.

Timeline

Start: 2019-08-26
Primary completion: 2021-07-06
Completion: 2021-07-06

Outcome

Met primary endpoint

paper Treatment 1 and 2 groups compared with the Control group at 8 weeks was -32.6 (3.7) % and -45.9 (3.3) %, respectively (P < .001). PMID 37814541 ↗

Publications

Kim BJ, Cha KS, Cho WH, Kim EJ, Choi SH, Kim MH, Kim SH, Park JB, Park SM, Sohn IS, Ryu KH, Chae IH. Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231205204. doi: 10.1177/10742484231205204.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rosuvastatin	Small molecule	5 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral
Comparator	Amlodipine	Other / unclassified	5 mg	Oral
Comparator	Olmesartan	Other / unclassified	20 mg	Oral