Hypertension
Conditions
Brief summary
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.
Detailed description
Study Design:
Interventions
start low dose and uptitrate to high dose on the basis of BP goal
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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 uncontrolled hypertension as defined SBP \> 140 mmHg and SBP \> 130 mmHg in patients with diabetes or renal impairment or DBP \> 90 mmHg and DBP \>80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min
Exclusion criteria
1. Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma). 3. Mean in-clinic seated cuff Systolic BP \>180 mmHg and SBP \>160 mmHg in patients with diabetes or renal impairment or Diastolic BP \>110 mmHg and DBP \>100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min. 4. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dl (or \>265 ¿mol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment. 5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. 6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., \<3.5 or \>5.5 mEq/L). 7. Uncorrected sodium or volume depletion. 8. Primary aldosteronism. 9. Hereditary fructose intolerance. 10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1). 11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator. 12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of \>2x bilirubin or \>2x transaminases values). (Refer to Appendix 10.3) 13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists. 14. History of drug or alcohol dependency within six months prior to signing the informed consent form. 15. Any investigational drug therapy within one month of signing the informed consent. 16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine). 17. History of non-compliance or inability to comply with prescribed medications or protocol procedures. 18. 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 |
|---|---|---|
| Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | 12 weeks | Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Week 12 | Achieving BP control with HBPM is defined as SBP\<135 mmHg and DBP\<85 mmHg. |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | weeks 4, 8 and 12 | — |
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | weeks 4, 8 and 12 | Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. |
| Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure | weeks 4, 8 and 12 | — |
| BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | 4 and 8 weeks | Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg. |
| Percentage of Patients in Blood Pressure Categories Over Time | weeks 4, 8 and 12 | 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. |
| DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | weeks 4, 8 and 12 | 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 |
| Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | weeks 4 and 8 | — |
| DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | weeks 4, 8 and 12 | 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. |
Countries
Germany, Italy, Mexico, Netherlands, Poland
Participant flow
Pre-assignment details
This was a prospective, single-arm, open-label, uncontrolled, multi-centre, international trial. Whilst 542 patients were enrolled, 502 entered the study. Since one patient refused to take study medication, only 501 patients were treated. The Full analysis set (FAS) consisted of 494 patients and this is the basis of most data presentations.
Participants by arm
| Arm | Count |
|---|---|
| T80/A5 Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination | 494 |
| Total | 494 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other | 6 |
| Overall Study | Protocol Violation | 12 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | T80/A5 |
|---|---|
| Age, Continuous | 58.0 Years STANDARD_DEVIATION 11.5 |
| Diastolic Blood Pressure (DBP) at time of baseline | 91.8 mmHg STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 207 Participants |
| Sex: Female, Male Male | 287 Participants |
| Systolic Blood Pressure (SBP) at time of baseline | 151.4 mmHg STANDARD_DEVIATION 10.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 501 | 41 / 232 |
| serious Total, serious adverse events | 1 / 501 | 1 / 232 |
Outcome results
Primary
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
Population: Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T80/A5 | Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | 67.6 Percentage of participants |
Secondary
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
Population: FAS and LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | Week 4 | 262 Number of participants |
| T80/A5 | BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | Week 8 | 330 Number of participants |
Secondary
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
Population: FAS and LOCF and with at least one post baseline HBPM measurement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Morning | 179 Number of participants |
| T80/A5 | BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Evening | 172 Number of participants |
Secondary
Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure
Time frame: weeks 4, 8 and 12
Population: There was no information in the Case Report Form (CRF)
Secondary
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
Population: Treated Set (TS) with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Change at week 4 (N=482) | 1.43 bpm | Standard Deviation 9.22 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Change at week 8 (N=463) | 0.32 bpm | Standard Deviation 9.21 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | Change at week 12 (N=344) | 0.51 bpm | Standard Deviation 9.25 |
Secondary
Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
Time frame: weeks 4, 8 and 12
Population: FAS with non-missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 4 SBP (N=485) | -13.58 mmHg | Standard Deviation 11.95 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 8 SBP (N=487) | -16.37 mmHg | Standard Deviation 12.34 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 12 SBP (N=487) | -16.92 mmHg | Standard Deviation 12.24 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 4 DBP (N=485) | -8.24 mmHg | Standard Deviation 8.77 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 8 DBP (N=487) | -10.33 mmHg | Standard Deviation 8.88 |
| T80/A5 | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | Change at week 12 DBP (N=487) | -10.43 mmHg | Standard Deviation 8.83 |
Secondary
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.
Time frame: weeks 4, 8 and 12
Population: FAS and LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 4 DBP control | 313 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 8 DBP control | 368 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 12 DBP control | 373 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 4 SBP control | 247 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 8 SBP control | 305 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 12 SBP control | 311 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 4 DBP response | 329 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 8 DBP response | 393 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 12 DBP response | 399 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 4 SBP response | 337 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 8 SBP response | 388 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | Week 12 SBP response | 393 Number of participants |
Secondary
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
Population: FAS and LOCF and with at least one post baseline HBPM measurement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control morning at week 8 | 242 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control morning at week 4 | 256 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control morning at week 12 | 252 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control evening at week 4 | 272 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control evening at week 8 | 247 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP control evening at week 12 | 263 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control morning at week 4 | 204 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control morning at week 8 | 198 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control morning at week 12 | 206 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control evening at week 4 | 204 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control evening at week 8 | 183 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP control evening at week 12 | 190 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response morning at week 4 (N=354) | 256 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response morning at week 8 (N=354) | 242 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response morning at week 12 (N=354) | 252 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response evening at week 4 (N=354) | 272 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response evening at week 8 (N=354) | 247 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | DBP response evening at week 12 (N=354) | 263 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response morning at week 4 (N=299) | 204 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response morning at week 8 (N=299) | 198 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response morning at week 12 (N=299) | 206 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response evening at week 4 (N=299) | 204 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response evening at week 8 (N=299) | 183 Number of participants |
| T80/A5 | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | SBP response evening at week 12 (N=299) | 190 Number of participants |
Secondary
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
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | Week 4 (n=482) | 186 Number of participants |
| T80/A5 | Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | Week 8 (n=284) | 46 Number of participants |
Secondary
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
Population: FAS with non-missing data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP optimal at week 4 (N=482) | 4.1 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP normal at week 4 (N=482) | 19.7 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP high-normal at week 4 (N=482) | 30.5 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 1 hypertension at week 4 (N=482) | 39.0 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 2 hypertension at week 4 (N=482) | 6.2 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 3 hypertension at week 4 (N=482) | 0.4 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP optimal at week 8 (N=487) | 5.5 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP normal at week 8 (N=487) | 22.2 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP high-normal at week 8 (N=487) | 40.0 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 1 hypertension at week 8 (N=487) | 27.7 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 2 hypertension at week 8 (N=487) | 4.3 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 3 hypertension at week 8 (N=487) | 0.2 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP optimal at week 12 (N=487) | 4.5 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP normal at week 12 (N=487) | 28.5 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | BP high-normal at week 12 (N=487) | 35.5 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 1 hypertension at week 12 (N=487) | 27.1 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 2 hypertension at week 12 (N=487) | 4.1 Percentage of participants |
| T80/A5 | Percentage of Patients in Blood Pressure Categories Over Time | Grade 3 hypertension at week 12 (N=487) | 0.2 Percentage of participants |