The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
894
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
The SBP value at baseline was subtracted from the SBP value at Week 7.
Time frame: Baseline and Week 7
Change From Baseline in Mean Seated Trough Cuff SBP to Week 5
The SBP value at baseline was subtracted from the SBP value at Week 5.
Time frame: Baseline and Week 5
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3
The SBP value at baseline was subtracted from the SBP value at Week 3.
Time frame: Baseline and Week 3
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7
The DBP value at baseline was subtracted from the DBP value at Week 7.
Time frame: Baseline and Week 7
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7
SBP control is defined as SBP \< 140 mmHg.
Time frame: Week 7 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5
SBP control is defined as SBP \< 140 mmHg
Time frame: Week 5 timepoint
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3
SBP control is defined as SBP \< 140 mmHg
Time frame: Week 3 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
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DBP control is defined as DBP\<90 mmHg
Time frame: Week 7 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5
DBP control is defined as DBP\<90 mmHg
Time frame: Week 5 timepoint
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3
DBP control is defined as DBP\<90 mmHg
Time frame: Week 3 timepoint
Number of Patients With Blood Pressure (BP) Control at Week 7
BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline SBP
Time frame: Week 7 timepoint
Number of Patients With BP Control at Week 7
BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline DBP
Time frame: Week 7 timepoint
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7
SBP response is defined as SBP\<140 mmHg or a reduction of \>= 15 mmHg
Time frame: Week 7 timepoint
Number of Participants With DBP Response at Week 7
DBP response is defined as DBP\<90 mmHg or a reduction of \>= 10 mmHg
Time frame: Week 7 timepoint
BP Categories at Week 7
BP categories comprise: * 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 hypertension') * Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
Time frame: Week 7 timepoint