Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Phase 4 Completed 894 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).

Timeline

Start: 2009-06
Primary completion: 2010-04
Completion: —

Outcome

Met primary endpoint

paper After 7 weeks, SBP was changed by -37.0 and -28.5 mm Hg in the T80/H25 and T80 groups (P < 0.0001); PMID 22717420 ↗

registry Mean Difference (Final Values) -8.5 (95% CI -10.6 to -6.4); ANCOVA NCT00926289 ↗

Publications

Zhu DL, Bays H, Gao P, Mattheus M, Voelker B, Ruilope LM. Efficacy and tolerability of initial therapy with single-pill combination telmisartan/hydrochlorothiazide 80/25 mg in patients with grade 2 or 3 hypertension: a multinational, randomized, double-blind, active-controlled trial. Clin Ther. 2012 Jul;34(7):1613-24. doi: 10.1016/j.clinthera.2012.05.007. Epub 2012 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrochlorothiazide	Unknown	25 mg	—
Subject	Telmisartan	Other / unclassified	80 mg	—