An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

Phase 3 Completed 324 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Timeline

Start: 2010-07
Primary completion: 2011-08
Completion: —

Outcome

Met primary endpoint

paper significantly greater with T80/A5 (12.4 ± 1.0 mmHg) than A5 (10.2 ± 0.9 mmHg [primary endpoint, n = 314]). PMID 24391142 ↗

registry analysis (superiority or other test); A5 Alone vs T80/A5; p = 0.007; Mean Difference (Final Values) 2.1881 (95% CI 0.6082 to 3.7681); ANCOVA NCT01103960 ↗

registry analysis (superiority or other test); A5 Alone vs T80/A5; p = 0.034; Mean Difference (Final Values) 1.9195 (95% CI 0.1443 to 3.6947); ANCOVA NCT01103960 ↗

Publications

Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amlodipine	Other / unclassified	5 mg	—
Subject	Telmisartan	Other / unclassified	80 mg	—