Hypertension Clinical Trial
Official title:
A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in
hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood
pressure beyond the target of 130/80 mmHg after one year of treatment.
The primary objective of this study is to show that telmisartan 80 mg is at least as
effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour
proteinuria after one year of treatment.
This is a randomised, double-blind, double-dummy, forced titration, multicentre, parallel
group trial in patients with essential hypertension, diabetes mellitus type 2 and diabetic
nephropathy.
After a 4-6 week Run-in period, patients are randomised to one of the treatment groups and
receive either Telmisartan 40 - 80 mg or Valsartan 80 - 160 mg. The treatment regimen is a
forced titration with the lower dose given for 2 weeks and the higher dose given for the
rest of the treatment period summing up to 52 weeks of treatment. During the treatment
period, 8 visits to the investigator are scheduled in order to control blood pressure, renal
function parameters and safety. In addition, parameters of endothelial function and
oxidative stress are measured at baseline, 6 months and after one year of treatment.
Study Hypothesis:
Non-inferiority of telmisartan 80 mg compared to valsartan 160 mg will be tested using the
following set of hypotheses:
Null Hypothesis:
The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for
telmisartan 80 mg is inferior to that for valsartan 160 mg by 0.5 g/day or more.
Alternative Hypothesis:
The overall mean change from baseline in UPER (24 hour urinary protein excretion rate) for
telmisartan 80 mg is less than 0.5 g/day worse than that for valsartan 160 mg.
Comparison(s):
In order to test the non-inferiority hypothesis, analysis of covariance with treatment and
centre as main effects and baseline as a covariate will be performed. Time-to-event data
will be analysed using the log-rank test.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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