drugset / Trial / NCT01975246
Add-on to Micamlo BP Trial
RandomizedParallel-groupDouble-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | — |
| Comparator | Amlodipine | Other / unclassified | 5 mg | — |
| Comparator | Telmisartan | Other / unclassified | 80 mg | — |