The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
Study Design:
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
start low dose and uptitrate to high dose on the basis of BP goal
Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
Time frame: 12 weeks
BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
Time frame: 4 and 8 weeks
BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
Achieving BP control with HBPM is defined as SBP\<135 mmHg and DBP\<85 mmHg.
Time frame: Week 12
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Time frame: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.
Time frame: weeks 4, 8 and 12
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure
Time frame: weeks 4, 8 and 12
DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1235.33.49010 Boehringer Ingelheim Investigational Site
Berlin, Germany
1235.33.49002 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1235.33.49007 Boehringer Ingelheim Investigational Site
Haag, Germany
1235.33.49003 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1235.33.49005 Boehringer Ingelheim Investigational Site
Künzing, Germany
1235.33.49008 Boehringer Ingelheim Investigational Site
Nuremberg, Germany
1235.33.49009 Boehringer Ingelheim Investigational Site
Rednitzhembach, Germany
1235.33.49006 Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen, Germany
1235.33.49004 Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany
1235.33.49001 Boehringer Ingelheim Investigational Site
Westerkappeln, Germany
...and 37 more locations
Time frame: weeks 4, 8 and 12
Percentage of Patients in Blood Pressure Categories Over Time
BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg.
Time frame: weeks 4, 8 and 12
DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
DBP control: DBP \<85 mmHg, SBP control: SBP \<135 mmHg, DBP response: DBP \<85 mmHg or a reduction from baseline \>=10 mmHg, SBP response: SBP \<135 mmHg or a reduction from baseline \>= 15 mmHg
Time frame: weeks 4, 8 and 12
Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
Time frame: weeks 4 and 8