Hypertension
Conditions
Brief summary
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).
Interventions
DRUGTelmisartan
Telmisartan 80mg
DRUGHydrochlorothiazide
Hydrochlorothiazide25mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation; 2. Age 18 years or older; 3. Patients with grade 2 or grade 3 hypertension as defined SBP\>=160 mmHg and DBP\>=100 mmHg at randomization 4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
Exclusion criteria
1. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study. 2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m. 3. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma) 4. Mean in-clinic seated cuff SBP\>= 200 mmHg and/or DBP \>=120 mmHg 5. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 umol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment. 6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney 7. Clinically relevant hypokalemia or hyperkalemia (i.e., \<3.5 mmol/L or \>5.5 mmol/L, may be rechecked for suspected error in result) 8. Uncorrected sodium or volume depletion 9. Primary aldosteronism. 10. Hereditary fructose intolerance 11. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency 12. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3) 13. Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period) 14. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator 15. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve 16. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin \>=10% 17. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists 18. History of drug or alcohol dependency within 6 months prior to signing the informed consent form 19. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol 20. Any investigational drug therapy within 1 month of signing the informed consent 21. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo) 22. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in) 23. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | Baseline and Week 7 | The SBP value at baseline was subtracted from the SBP value at Week 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | Baseline and Week 3 | The SBP value at baseline was subtracted from the SBP value at Week 3. |
| Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | Baseline and Week 7 | The DBP value at baseline was subtracted from the DBP value at Week 7. |
| Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Week 7 timepoint | SBP control is defined as SBP \< 140 mmHg. |
| Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | Week 5 timepoint | SBP control is defined as SBP \< 140 mmHg |
| Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | Week 3 timepoint | SBP control is defined as SBP \< 140 mmHg |
| Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | Week 7 timepoint | DBP control is defined as DBP\<90 mmHg |
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | Baseline and Week 5 | The SBP value at baseline was subtracted from the SBP value at Week 5. |
| Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | Week 3 timepoint | DBP control is defined as DBP\<90 mmHg |
| Number of Patients With Blood Pressure (BP) Control at Week 7 | Week 7 timepoint | BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline SBP |
| Number of Patients With BP Control at Week 7 | Week 7 timepoint | BP control is defined as SBP\<140 mmHg and DBP \< 90 mmHg and is adjusted for baseline DBP |
| Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 | Week 7 timepoint | SBP response is defined as SBP\<140 mmHg or a reduction of \>= 15 mmHg |
| Number of Participants With DBP Response at Week 7 | Week 7 timepoint | DBP response is defined as DBP\<90 mmHg or a reduction of \>= 10 mmHg |
| BP Categories at Week 7 | Week 7 timepoint | 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) |
| Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | Week 5 timepoint | DBP control is defined as DBP\<90 mmHg |
Countries
Bulgaria, China, France, Georgia, Romania, Russia, South Korea, United States
Participant flow
Pre-assignment details
894 patients were entered (randomised) into the study; however, of these, 6 were not treated. Therefore 888 patients actually entered into treatment.
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan 40/80 mg Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks | 294 |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks | 594 |
| Total | 888 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 11 |
| Overall Study | Lost to Follow-up | 3 | 6 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Protocol Violation | 8 | 12 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Telmisartan 40/80 mg | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Total |
|---|---|---|---|
| Age, Continuous | 57.6 Years STANDARD_DEVIATION 11.9 | 56.8 Years STANDARD_DEVIATION 11.3 | 57.0 Years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 125 Participants | 285 Participants | 410 Participants |
| Sex: Female, Male Male | 169 Participants | 309 Participants | 478 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 294 | 0 / 594 |
| serious Total, serious adverse events | 1 / 294 | 0 / 594 |
Outcome results
Primary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40/80 mg | Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | -28.5 mmHg | Standard Error 0.88 |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | -37.0 mmHg | Standard Error 0.62 |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [-10.6, -6.4]ANCOVA
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40/80 mg | BP Categories at Week 7 | Grade 2 hypertension | 44 Participants |
| Telmisartan 40/80 mg | BP Categories at Week 7 | BP normal | 36 Participants |
| Telmisartan 40/80 mg | BP Categories at Week 7 | BP optimal | 6 Participants |
| Telmisartan 40/80 mg | BP Categories at Week 7 | Grade 1 hypertension | 120 Participants |
| Telmisartan 40/80 mg | BP Categories at Week 7 | Grade 3 hypertension | 22 Participants |
| Telmisartan 40/80 mg | BP Categories at Week 7 | BP high normal | 57 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | Grade 3 hypertension | 11 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | BP high normal | 138 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | Grade 1 hypertension | 186 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | Grade 2 hypertension | 58 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | BP normal | 136 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | BP Categories at Week 7 | BP optimal | 44 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.0001Van Elteren test stratified for country
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40/80 mg | Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | -15.4 mmHg | Standard Error 0.55 |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | -18.6 mmHg | Standard Error 0.38 |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [-4.5, -1.9]ANCOVA
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40/80 mg | Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | -26.5 mmHg | Standard Error 0.87 |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | -33.3 mmHg | Standard Error 0.61 |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [-8.8, -4.7]ANCOVA
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40/80 mg | Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | -28.6 mmHg | Standard Error 0.86 |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | -35.8 mmHg | Standard Error 0.61 |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [-9.3, -5.2]ANCOVA
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Participants With DBP Response at Week 7 | 202 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Participants With DBP Response at Week 7 | 483 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.57, 3.16]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With Blood Pressure (BP) Control at Week 7 | 99 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With Blood Pressure (BP) Control at Week 7 | 318 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.76, 3.26]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With BP Control at Week 7 | 99 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With BP Control at Week 7 | 318 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.78, 3.29]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | 131 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | 343 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: 0.000595% CI: [1.28, 2.37]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | 150 participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | 391 participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.48, 2.76]Regression, Logistic
Secondary
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
DBP control is defined as DBP\<90 mmHg
Time frame: Week 7 timepoint
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | 150 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | 389 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.46, 2.73]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | 97 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | 306 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.6, 3.01]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | 119 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | 355 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.7, 3.12]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | 122 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | 363 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.74, 3.21]Regression, Logistic
Secondary
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
Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 40/80 mg | Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 | 233 Participants |
| Telmisartan 40/80 mg + HCTZ 12.5/25 mg | Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 | 527 Participants |
Comparison: T80+HCTZ25 versus T80 monotherapyp-value: <0.000195% CI: [1.7, 4.04]Regression, Logistic