The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
947
Change From Baseline in Trough Seated Diastolic Blood Pressure
Change from baseline to the end of study in trough DBP
Time frame: Baseline and end of study (8 weeks or last value on treatment)
Change From Baseline in Trough Seated Systolic Blood Pressure
Change from baseline to the end of study in trough SBP
Time frame: Baseline and end of study (8 weeks or last value on treatment)
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)
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 Diastolic Blood Pressure <80 mmHg
The number of patients who reach the target DBP of \<80mmHg
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)
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1235.6.61003 Boehringer Ingelheim Investigational Site
Gosford, New South Wales, Australia
1235.6.61004 Boehringer Ingelheim Investigational Site
Liverpool, New South Wales, Australia
1235.6.61002 Boehringer Ingelheim Investigational Site
Kippa-Ring, Queensland, Australia
1235.6.61001 Boehringer Ingelheim Investigational Site
Milton, Queensland, Australia
1235.6.61005 Boehringer Ingelheim Investigational Site
Elizabeth Vale, South Australia, Australia
1235.6.43007 Boehringer Ingelheim Investigational Site
Eggenburg, Austria
1235.6.43006 Boehringer Ingelheim Investigational Site
Hainburg A.d. Donau, Austria
1235.6.43005 Boehringer Ingelheim Investigational Site
Hartberg, Austria
1235.6.43001 Boehringer Ingelheim Investigational Site
Vienna, Austria
1235.6.43002 Boehringer Ingelheim Investigational Site
Vienna, Austria
...and 87 more locations
Trough Seated BP Normality Classes
The number of patients who reach predefined BP categories
Time frame: End of study (8 weeks or last value on treatment)
Oedema Incidence Rate
The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)
Time frame: During randomised treatment period
Peripheral Oedema Incidence Rate
The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
Time frame: During randomised treatment period