Add-on to Micamlo BP Trial

Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Timeline

Start

2013-11

Primary completion

2014-06

Completion

2014-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Telmisartan and Amlodipine+HCTZ vs Telmisartan+Amlodipine; p <0.0001; Mean Difference (Final Values) -3.9 (95% CI -5.3 to -2.4); ANCOVA NCT01975246 ↗

Drugs

Indications