The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
1,098
1235.5.32004 Boehringer Ingelheim Investigational Site
Aywaille, Belgium
1235.5.32001 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1235.5.32010 Boehringer Ingelheim Investigational Site
Gozée, Belgium
1235.5.32008 Boehringer Ingelheim Investigational Site
Linkebeek, Belgium
1235.5.32003 Boehringer Ingelheim Investigational Site
Mol, Belgium
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)
Change from baseline to the end of study in trough DBP
Time frame: End of study (8 weeks or last value on treatment)
Number of Patients With Oedema
Patients from the treated set who experienced at least one case of general oedema.
Time frame: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)
Change from baseline to the end of study in trough SBP
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control
The number of patients who reach the target DBP of \<90mmHg
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated DBP Response
The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Control
The number of patients who reach the target SBP of \<140mmHg
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated SBP Response
The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Time frame: End of study (8 weeks or last value on treatment)
Trough Seated Blood Pressure (BP) Normality Classes
The number of patients who reach predefined BP categories: * Optimal - SBP\<120 and DBP\<80 mmHg * Normal - SBP\<130 and DBP\<85 mmHg * High-normal - SBP\<140 DBP\<90 mmHg * Stage 1 hypertension - SBP\<160 and DBP\<100 * Stage 2 hypertension SBP\>=160 and DBP\>=100 mmHg
Time frame: End of study (8 weeks or last value on treatment)
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1235.5.32007 Boehringer Ingelheim Investigational Site
Natoye, Belgium
1235.5.32009 Boehringer Ingelheim Investigational Site
Tavier, Belgium
1235.5.32002 Boehringer Ingelheim Investigational Site
Tienen-Kumtich, Belgium
1235.5.32005 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
1235.5.20001 Boehringer Ingelheim Investigational Site
Coquitlam, British Columbia, Canada
...and 119 more locations