Hypertension
Conditions
Brief summary
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
Interventions
DRUGTelmisartan 80
Telmisartan 80 mg
DRUGAmlodipine 10
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
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. Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure \>150 mmHg at Visit 3 (Randomisation visit) 2. Diagnosis of Type 2 diabetes mellitus 3. =18 years of age at the date of signing the informed consent 4. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion) 5. Ability to provide written informed consent
Exclusion criteria
1. Pre-menopausal women (last menstruation \<=1 year prior to start of run-in period) who: 1. are not surgically sterile; and/or 2. are nursing or pregnant, or 3. are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study. The only acceptable methods of birth control are: * Intrauterine device (IUD); * Oral contraceptives (started at least three months prior to start of run-in period) * Implantable or injectable contraceptives and * Estrogen patch 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, phaeochromocytoma) 4. Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods 5. Patients with Type 1 diabetes mellitus 6. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 µmol /L) or known creatinine clearance \<30 mL/min or clinical markers of severe renal impairment 7. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney 8. Clinically relevant hypokalaemia or hyperkalaemia 9. Uncorrected sodium or volume depletion 10. Primary aldosteronism 11. Hereditary fructose intolerance 12. Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency 13. Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3) 14. Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period) 15. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator 16. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve 17. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C \>10% 18. Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists 19. History of drug or alcohol dependency within six months prior to signing the informed consent form 20. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol 21. Any investigational drug therapy within one month of signing the informed consent 22. Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo) 23. History of non-compliance or inability to comply with prescribed medications or protocol procedures 24. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 | Baseline, week 8 | Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SBP Response 130 at Two Weeks | Baseline, week 2 | SBP \<130 mmHg or a reduction \>=10 mmHg |
| SBP Response 130 at One Week | Baseline, week 1 | SBP \<130 mmHg or a reduction \>=10 mmHg |
| DBP Response at Eight Weeks | Week 8 | Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg |
| Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 | Baseline, week 6 | Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. |
| Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 | Baseline, week 4 | Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. |
| DBP Response at Six Weeks | week 6 | Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg |
| DBP Response at Week Four | Week 4 | Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg |
| Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 | Baseline, week 2 | Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. |
| Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 | Baseline, week 1 | Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication. |
| Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks | Baseline, week 8 | Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg |
| BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks | Baseline, week 6 | Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg |
| BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks | Baseline, week 4 | Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg |
| BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks | Baseline, week 2 | Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg |
| BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week | Baseline, week 1 | Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg |
| DBP Response at Week Two | Week 2 | Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg |
| DBP Response at Week One | Week 1 | Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg |
| Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) | 8 weeks | Change from baseline in UACR (measured in spot urine) after eight weeks of treatment |
| BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks | Baseline, week 8 | Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg |
| BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks | Baseline, week 6 | Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg |
| BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks | Baseline, week 4 | Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg |
| BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks | Baseline, week 2 | Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg |
| BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week | Baseline, week 1 | Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg |
| Systolic Blood Pressure (SBP) Control 140 at Eight Weeks | Baseline, week 8 | Mean seated SBP \< 140 mmHg |
| SBP Control 140 at Six Weeks | Baseline, week 6 | Mean seated SBP \< 140 mmHg |
| SBP Control 140 at Four Weeks | Baseline, week 4 | Mean seated SBP \< 140 mmHg |
| SBP Control 140 at Two Weeks | Baseline, week 2 | Mean seated SBP \< 140 mmHg |
| SBP Control 140 at One Week | Baseline, week 1 | Mean seated SBP \< 140 mmHg |
| SBP Control 130 at Eight Weeks | Baseline, week 8 | Mean seated SBP \< 130 mmHg |
| SBP Control 130 at Six Weeks | Baseline, week 6 | Mean seated SBP \< 130 mmHg |
| SBP Control 130 at Four Weeks | Baseline, week 4 | Mean seated SBP \< 130 mmHg |
| SBP Control 130 at Two Weeks | Baseline, week 2 | Mean seated SBP \< 130 mmHg |
| SBP Control 130 at One Week | Baseline, week 1 | Mean seated SBP \< 130 mmHg |
| SBP Response 140 at Eight Weeks | Baseline, week 8 | SBP \< 140 mmHg or a reduction \>=10 mmHg |
| SBP Response 140 at Six Weeks | Baseline, week 6 | SBP \<140 mmHg or a reduction \>=10 mmHg |
| SBP Response 130 at Four Weeks | Baseline, week 4 | SBP \<130 mmHg or a reduction \>=10 mmHg |
| SBP Response 140 at Two Weeks | Baseline, week 2 | SBP \<140 mmHg or a reduction \>=10 mmHg |
| SBP Response 140 at One Week | Baseline, week 1 | SBP \<140 mmHg or a reduction \>=10 mmHg |
| SBP Response 130 at Eight Weeks | Baseline, week 8 | SBP \<130 mmHg or a reduction \>=10 mmHg |
| SBP Response 130 at Six Weeks | Baseline, week 6 | SBP \<130 mmHg or a reduction \>=10 mmHg |
| SBP Response 140 at Four Weeks | Baseline, week 4 | SBP \<140 mmHg or a reduction \>=10 mmHg |
Countries
Argentina, Mexico, Netherlands, Slovakia, South Africa, South Korea, Spain, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks. | 352 |
| Amlodipine 10 mg Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks. | 354 |
| Total | 706 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 20 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other reason (not specified) | 2 | 6 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Telmisartan 80 mg + Amlodipine 10 mg | Amlodipine 10 mg |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 10.1 | 60.5 years STANDARD_DEVIATION 10.4 | 60.5 years STANDARD_DEVIATION 9.7 |
| Age, Customized < 65 years | 449 participants | 214 participants | 235 participants |
| Age, Customized >= 65 years | 257 participants | 138 participants | 119 participants |
| Alcohol history Drinks - no interference | 261 participants | 125 participants | 136 participants |
| Alcohol history Non drinker | 445 participants | 227 participants | 218 participants |
| Body Mass Index | 32.0 kilogram / square meter STANDARD_DEVIATION 6.1 | 32.1 kilogram / square meter STANDARD_DEVIATION 6 | 31.8 kilogram / square meter STANDARD_DEVIATION 6.1 |
| Body Mass Index Class < 25 kg/square meter | 63 participants | 32 participants | 31 participants |
| Body Mass Index Class 25 to <30 kg/square meter | 237 participants | 114 participants | 123 participants |
| Body Mass Index Class >= 30 kg/square meter | 406 participants | 206 participants | 200 participants |
| Height | 167.4 centimeter STANDARD_DEVIATION 10.6 | 167.1 centimeter STANDARD_DEVIATION 10.3 | 167.6 centimeter STANDARD_DEVIATION 10.9 |
| Race class Black | 84 participants | 43 participants | 41 participants |
| Race class Non-black | 622 participants | 309 participants | 313 participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 12 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized Asian | 70 participants | 30 participants | 40 participants |
| Race/Ethnicity, Customized Black/African American | 84 participants | 43 participants | 41 participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized White | 538 participants | 270 participants | 268 participants |
| Region of Enrollment Argentina | 64 participants | 33 participants | 31 participants |
| Region of Enrollment Mexico | 56 participants | 27 participants | 29 participants |
| Region of Enrollment Netherlands | 86 participants | 44 participants | 42 participants |
| Region of Enrollment Republic of Korea | 20 participants | 9 participants | 11 participants |
| Region of Enrollment Slovakia | 76 participants | 36 participants | 40 participants |
| Region of Enrollment South Africa | 105 participants | 53 participants | 52 participants |
| Region of Enrollment Spain | 37 participants | 19 participants | 18 participants |
| Region of Enrollment Sweden | 21 participants | 11 participants | 10 participants |
| Region of Enrollment United States | 241 participants | 120 participants | 121 participants |
| Sex: Female, Male Female | 341 Participants | 172 Participants | 169 Participants |
| Sex: Female, Male Male | 365 Participants | 180 Participants | 185 Participants |
| Smoking history Currently smokes | 83 participants | 40 participants | 43 participants |
| Smoking history Ex-smoker | 180 participants | 91 participants | 89 participants |
| Smoking history Never smoked | 443 participants | 221 participants | 222 participants |
| Weight | 89.9 kilogram STANDARD_DEVIATION 20.2 | 90.2 kilogram STANDARD_DEVIATION 20.9 | 89.5 kilogram STANDARD_DEVIATION 19.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 62 / 352 | 71 / 354 |
| serious Total, serious adverse events | 3 / 352 | 4 / 354 |
Outcome results
Primary
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Time frame: Baseline, week 8
Population: Treated Set includes all randomized participants who took at least one dose of treatment
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 | -29.0 mmHg | Standard Error 0.66 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 | -22.9 mmHg | Standard Error 0.67 |
p-value: 0.000195% CI: [-7.9, -4.2]ANCOVA
Secondary
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Time frame: Baseline, week 8
Population: Treated set using last observation carried forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks | 237 participants |
| Amlodipine 10 mg | Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks | 177 participants |
Secondary
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Time frame: Baseline, week 8
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks | 121 participants |
| Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks | 59 participants |
Secondary
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks | 94 participants |
| Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks | 38 participants |
Secondary
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week | 35 participants |
| Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week | 12 participants |
Secondary
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks | 134 participants |
| Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks | 60 participants |
Secondary
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
Mean seated SBP\<130 mmHg and mean seated DBP\<80 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks | 58 participants |
| Amlodipine 10 mg | BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks | 23 participants |
Secondary
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks | 235 participants |
| Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks | 155 participants |
Secondary
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week | 130 participants |
| Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week | 72 participants |
Secondary
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks | 245 participants |
| Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks | 168 participants |
Secondary
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
Mean seated SBP\<140 mmHg and mean seated DBP\<90 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks | 184 participants |
| Amlodipine 10 mg | BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks | 103 participants |
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Time frame: Baseline, week 1
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 | -17.5 mmHg | Standard Error 0.61 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 | -12.6 mmHg | Standard Error 0.61 |
p-value: 0.000195% CI: [-6.6, -3.2]ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Time frame: Baseline, week 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 | -22.4 mmHg | Standard Error 0.65 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 | -16.4 mmHg | Standard Error 0.65 |
p-value: 0.000195% CI: [-7.9, -4.3]ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Time frame: Baseline, week 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 | -27.7 mmHg | Standard Error 0.62 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 | -21.1 mmHg | Standard Error 0.62 |
p-value: 0.000195% CI: [-8.3, -4.9]ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
Time frame: Baseline, week 6
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 | -29.7 mmHg | Standard Error 0.62 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 | -22.6 mmHg | Standard Error 0.63 |
p-value: 0.000195% CI: [-8.9, -5.4]ANCOVA
Secondary
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
Change from baseline in UACR (measured in spot urine) after eight weeks of treatment
Time frame: 8 weeks
Population: Treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) | -0.36 ratio | Standard Deviation 0.79 |
| Amlodipine 10 mg | Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) | 0.04 ratio | Standard Deviation 0.92 |
Secondary
DBP Response at Eight Weeks
Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
Time frame: Week 8
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | DBP Response at Eight Weeks | 253 participants |
| Amlodipine 10 mg | DBP Response at Eight Weeks | 214 participants |
Secondary
DBP Response at Six Weeks
Mean seated DBP\<80 mmHg or a reduction of \<=10 mmHg
Time frame: week 6
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | DBP Response at Six Weeks | 275 participants |
| Amlodipine 10 mg | DBP Response at Six Weeks | 214 participants |
Secondary
DBP Response at Week Four
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Time frame: Week 4
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | DBP Response at Week Four | 250 participants |
| Amlodipine 10 mg | DBP Response at Week Four | 190 participants |
Secondary
DBP Response at Week One
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Time frame: Week 1
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | DBP Response at Week One | 165 participants |
| Amlodipine 10 mg | DBP Response at Week One | 113 participants |
Secondary
DBP Response at Week Two
Mean seated DBP \<80 mmHg or a reduction of \>=10 mmHg
Time frame: Week 2
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | DBP Response at Week Two | 206 participants |
| Amlodipine 10 mg | DBP Response at Week Two | 166 participants |
Secondary
SBP Control 130 at Eight Weeks
Mean seated SBP \< 130 mmHg
Time frame: Baseline, week 8
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 130 at Eight Weeks | 157 participants |
| Amlodipine 10 mg | SBP Control 130 at Eight Weeks | 89 participants |
Secondary
SBP Control 130 at Four Weeks
Mean seated SBP \< 130 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 130 at Four Weeks | 137 participants |
| Amlodipine 10 mg | SBP Control 130 at Four Weeks | 70 participants |
Secondary
SBP Control 130 at One Week
Mean seated SBP \< 130 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 130 at One Week | 50 participants |
| Amlodipine 10 mg | SBP Control 130 at One Week | 26 participants |
Secondary
SBP Control 130 at Six Weeks
Mean seated SBP \< 130 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 130 at Six Weeks | 164 participants |
| Amlodipine 10 mg | SBP Control 130 at Six Weeks | 81 participants |
Secondary
SBP Control 130 at Two Weeks
Mean seated SBP \< 130 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 130 at Two Weeks | 92 participants |
| Amlodipine 10 mg | SBP Control 130 at Two Weeks | 42 participants |
Secondary
SBP Control 140 at Four Weeks
Mean seated SBP \< 140 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 140 at Four Weeks | 243 participants |
| Amlodipine 10 mg | SBP Control 140 at Four Weeks | 163 participants |
Secondary
SBP Control 140 at One Week
Mean seated SBP \< 140 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 140 at One Week | 141 participants |
| Amlodipine 10 mg | SBP Control 140 at One Week | 81 participants |
Secondary
SBP Control 140 at Six Weeks
Mean seated SBP \< 140 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 140 at Six Weeks | 251 participants |
| Amlodipine 10 mg | SBP Control 140 at Six Weeks | 177 participants |
Secondary
SBP Control 140 at Two Weeks
Mean seated SBP \< 140 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Control 140 at Two Weeks | 193 participants |
| Amlodipine 10 mg | SBP Control 140 at Two Weeks | 112 participants |
Secondary
SBP Response 130 at Eight Weeks
SBP \<130 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 8
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 130 at Eight Weeks | 309 participants |
| Amlodipine 10 mg | SBP Response 130 at Eight Weeks | 288 participants |
Secondary
SBP Response 130 at Four Weeks
SBP \<130 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 130 at Four Weeks | 309 participants |
| Amlodipine 10 mg | SBP Response 130 at Four Weeks | 274 participants |
Secondary
SBP Response 130 at One Week
SBP \<130 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 130 at One Week | 253 participants |
| Amlodipine 10 mg | SBP Response 130 at One Week | 199 participants |
Secondary
SBP Response 130 at Six Weeks
SBP \<130 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 130 at Six Weeks | 318 participants |
| Amlodipine 10 mg | SBP Response 130 at Six Weeks | 286 participants |
Secondary
SBP Response 130 at Two Weeks
SBP \<130 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 130 at Two Weeks | 297 participants |
| Amlodipine 10 mg | SBP Response 130 at Two Weeks | 246 participants |
Secondary
SBP Response 140 at Eight Weeks
SBP \< 140 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 8
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 140 at Eight Weeks | 309 participants |
| Amlodipine 10 mg | SBP Response 140 at Eight Weeks | 288 participants |
Secondary
SBP Response 140 at Four Weeks
SBP \<140 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 4
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 140 at Four Weeks | 309 participants |
| Amlodipine 10 mg | SBP Response 140 at Four Weeks | 274 participants |
Secondary
SBP Response 140 at One Week
SBP \<140 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 1
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 140 at One Week | 253 participants |
| Amlodipine 10 mg | SBP Response 140 at One Week | 201 participants |
Secondary
SBP Response 140 at Six Weeks
SBP \<140 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 6
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 140 at Six Weeks | 318 participants |
| Amlodipine 10 mg | SBP Response 140 at Six Weeks | 286 participants |
Secondary
SBP Response 140 at Two Weeks
SBP \<140 mmHg or a reduction \>=10 mmHg
Time frame: Baseline, week 2
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | SBP Response 140 at Two Weeks | 297 participants |
| Amlodipine 10 mg | SBP Response 140 at Two Weeks | 246 participants |
Secondary
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
Mean seated SBP \< 140 mmHg
Time frame: Baseline, week 8
Population: Treated set using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 80 mg + Amlodipine 10 mg | Systolic Blood Pressure (SBP) Control 140 at Eight Weeks | 243 participants |
| Amlodipine 10 mg | Systolic Blood Pressure (SBP) Control 140 at Eight Weeks | 187 participants |