Conditions: Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 309
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet arm 2: telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet

Interventions: intervention 1: Telmisartan + amlodipine intervention 2: hydrochlorothiazide intervention 3: Telmisartan + amlodipine intervention 4: Placebo
Intervention descriptions: intervention 1: FDC tablet intervention 2: tablet intervention 3: FDC tablet intervention 4: placebo matching hydrochlorothiazide tablet

Protocol document: