Hypertension Clinical Trial
Official title:
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg
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+
hydrochlorothiazide 12.5 mg (T80/H12.5 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+ hydrochlorothiazide 12.5 mg.
Patients are assigned to one of the two groups after a 6-week open-label run-in period
taking T80/H12.5 mg.
In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide
12.5 mg will be evaluated in a 52-week extension period.
In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg
group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5
mg group change to the T80/A5/H12.5 mg therapy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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