Efficacy/Safety of Telmisartan/Amlodipine/Rosuvastatin in Hypertensive Patients With Hyperlipidemia

Summary

A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia

Timeline

Start

2015-11-24

Primary completion

2017-06-16

Completion

2017-06-16

Outcome

Met primary endpoint

paper were -51.9% (3.0%) in the TAR group and -3.2% (2.9%) in the TA group (P < 0.001). PMID 30904178 ↗

paper sitSBP were -28.3 (2.4) mm Hg in the TAR group and -10.7 (2.1) mm Hg in the TR group (P < 0.001). PMID 30904178 ↗

Publications

• Kim TS, Rha SW, Kim SY, Park DG, Sung KC, Yoon MH, Kim KH, Lee HC, Kim WS, Kim YJ, Ahn JC, Rhee MY, Cha DH, Yoo BS, Park SH, Yoo KD, Jeon DW, Yoon YW, Cho SK, Oh YS. Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study. Clin Ther. 2019 Apr;41(4):728-741. doi: 10.1016/j.clinthera.2019.02.013. Epub 2019 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	10 mg	—
Subject	Rosuvastatin	Small molecule	20 mg	—
Subject	Rosuvastatin	Small molecule	80 mg	—
Comparator	Telmisartan	Other / unclassified	20 mg	—
Comparator	Telmisartan	Other / unclassified	80 mg	—

Indications