Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Placebo-controlled, 4x4 Factorial Design Trial to Evaluate Telmisartan 20, 40 and 80 mg Tablets in Combination With Amlodipine 2.5, 5 and 10 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281580
• Other study ID #: 1235.1
• Secondary ID: 2008-000874-19
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2006
• Last updated: February 10, 2014
• Start date: April 2006

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina:Brazil:Mexico:South Africa:United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1461
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Main Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion criteria:

Exclusion Criteria:

1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.

2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
• Placebo
Placebo to Telmisartan and Amlodipine once daily for eight weeks
• Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
• Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
• Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks
• Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
• Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
• Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks
• Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
• Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
• Amlodipine 5 mg
amlodipine 5g once daily for eight weeks
• Telmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
• Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
• Amlodipine 5 mg
amlodipine 5mg once daily for eight weeks
• Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
• Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
• Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks
• Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
• Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
• Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
• Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
• Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
• Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
• Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
• Amlodipine 5 mg
amlodipine 5g once daily for two weeks
• Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
• Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
• Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
• Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks

Locations

Country	Name	City	State
Argentina	1235.1.001 Boehringer Ingelheim Investigational Site	BsAs
Argentina	1235.1.004 Boehringer Ingelheim Investigational Site	Buenos Aires
Argentina	1235.1.005 Boehringer Ingelheim Investigational Site	Buenos Aires
Argentina	1235.1.006 Boehringer Ingelheim Investigational Site	Buenos Aires
Argentina	1235.1.002 Boehringer Ingelheim Investigational Site	Carlos Paz
Argentina	1235.1.003 Boehringer Ingelheim Investigational Site	Cordoba
Brazil	1235.1.115 Universidade Federal do Pará	Belém
Brazil	1235.1.102 Liga de Hipertensão Arterial	Goiania
Brazil	1235.1.101 Clínica Médica	Rio de Janeiro
Brazil	1235.1.103 Unidade de Hipertensão - ICHC -	São Paulo
Brazil	1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão	São Paulo
Mexico	1235.1.203	Col. Magdalena de las Salinas
Mexico	1235.1.210 Consultorio Privado	Durango, Durango
Mexico	1235.1.202	Guadalajara, Jalisco
Mexico	1235.1.209 Boehringer Ingelheim Investigational Site	Guadalajara, Jalisco
Mexico	1235.1.204	Lomas de Guevara, Guadalajara
Mexico	1235.1.212 en Factores de riesgo cardiovascular	Mexico
Mexico	1235.1.208 "Ignacio Chávez"	mexico DF
Mexico	1235.1.211 Obesidad Y Prevencion de Enfermedades	Mexico, D.F.
Mexico	1235.1.205 Fraccionamiento Industrias	San Luis Potosi
Mexico	1235.1.207	Zapopan, Jalisco
South Africa	1235.1.314 Boehringer Ingelheim Investigational Site	Benoni
South Africa	1235.1.302 Boehringer Ingelheim Investigational Site	Boksburg
South Africa	1235.1.306 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1235.1.309 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1235.1.310 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1235.1.311 Boehringer Ingelheim Investigational Site	Cape Town
South Africa	1235.1.304 Boehringer Ingelheim Investigational Site	Durban
South Africa	1235.1.312 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1235.1.313 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	1235.1.307 Boehringer Ingelheim Investigational Site	Krugersdorp
South Africa	1235.1.303 Boehringer Ingelheim Investigational Site	Lenasia
South Africa	1235.1.305 Boehringer Ingelheim Investigational Site	Lenasia
South Africa	1235.1.301 Boehringer Ingelheim Investigational Site	Pretoria
South Africa	1235.1.308 Boehringer Ingelheim Investigational Site	Pretoria
United States	1235.1.435 Boehringer Ingelheim Investigational Site	Arkansas City	Kansas
United States	1235.1.442 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1235.1.424 Boehringer Ingelheim Investigational Site	Bay City	Michigan
United States	1235.1.433 Boehringer Ingelheim Investigational Site	Beaufort	South Carolina
United States	1235.1.437 Boehringer Ingelheim Investigational Site	Burke	Virginia
United States	1235.1.410 Boehringer Ingelheim Investigational Site	Burlington	North Carolina
United States	1235.1.399 Boehringer Ingelheim Investigational Site	Carrollton	Texas
United States	1235.1.429 Boehringer Ingelheim Investigational Site	Chandler	Arizona
United States	1235.1.400 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina
United States	1235.1.426 Boehringer Ingelheim Investigational Site	Cherry Hill	New Jersey
United States	1235.1.374 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1235.1.446 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1235.1.354 Boehringer Ingelheim Investigational Site	Cooper City	Florida
United States	1235.1.417 Boehringer Ingelheim Investigational Site	Cordova	Tennessee
United States	1235.1.391 Boehringer Ingelheim Investigational Site	Cudahy	California
United States	1235.1.460 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1235.1.451 Boehringer Ingelheim Investigational Site	Deland	Florida
United States	1235.1.370 Boehringer Ingelheim Investigational Site	East Providence	Rhode Island
United States	1235.1.366 Boehringer Ingelheim Investigational Site	East Syracuse	New York
United States	1235.1.444 Boehringer Ingelheim Investigational Site	Encinitas	California
United States	1235.1.445 Boehringer Ingelheim Investigational Site	Encino	California
United States	1235.1.408 Boehringer Ingelheim Investigational Site	Erie	Pennsylvania
United States	1235.1.373 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	1235.1.375 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	1235.1.457 Boehringer Ingelheim Investigational Site	Fairhope	Alabama
United States	1235.1.385 Boehringer Ingelheim Investigational Site	Florissant	Missouri
United States	1235.1.452 Boehringer Ingelheim Investigational Site	Florissant	Missouri
United States	1235.1.372 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida
United States	1235.1.396 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida
United States	1235.1.447 Boehringer Ingelheim Investigational Site	Fredericksburg	Virginia
United States	1235.1.443 Boehringer Ingelheim Investigational Site	Georgetown	Texas
United States	1235.1.422 Boehringer Ingelheim Investigational Site	Greenboro	North Carolina
United States	1235.1.438 Boehringer Ingelheim Investigational Site	Gurnee	Illinois
United States	1235.1.454 Boehringer Ingelheim Investigational Site	Henderson	Nevada
United States	1235.1.390 Boehringer Ingelheim Investigational Site	Hialeah	Florida
United States	1235.1.368 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	1235.1.389 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	1235.1.411 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	1235.1.415 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana
United States	1235.1.459 Boehringer Ingelheim Investigational Site	Jackson	Tennessee
United States	1235.1.365 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	1235.1.431 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	1235.1.416 Boehringer Ingelheim Investigational Site	Killeen	Texas
United States	1235.1.430 Boehringer Ingelheim Investigational Site	Kissimmee	Florida
United States	1235.1.402 Boehringer Ingelheim Investigational Site	Lake Jackson	Texas
United States	1235.1.404 Boehringer Ingelheim Investigational Site	Lansdale	Pennsylvania
United States	1235.1.379 Boehringer Ingelheim Investigational Site	Lenexa	Kansas
United States	1235.1.403 Boehringer Ingelheim Investigational Site	Lenior	North Carolina
United States	1235.1.357 Boehringer Ingelheim Investigational Site	Long Beach	California
United States	1235.1.465 Boehringer Ingelheim Investigational Site	Los Angeles	California
United States	1235.1.423 Boehringer Ingelheim Investigational Site	Louisville	Kentucky
United States	1235.1.413 Boehringer Ingelheim Investigational Site	Marion	Ohio
United States	1235.1.432 Boehringer Ingelheim Investigational Site	McKinney	Texas
United States	1235.1.351 Boehringer Ingelheim Investigational Site	Melbourne	Florida
United States	1235.1.398 Boehringer Ingelheim Investigational Site	Melbourne	Florida
United States	1235.1.453 Boehringer Ingelheim Investigational Site	Milford	Connecticut
United States	1235.1.405 Boehringer Ingelheim Investigational Site	Mirimar	Florida
United States	1235.1.363 Boehringer Ingelheim Investigational Site	New Tazewell	Tennessee
United States	1235.1.394 Boehringer Ingelheim Investigational Site	Newark	Delaware
United States	1235.1.421 Boehringer Ingelheim Investigational Site	Newtown	Kansas
United States	1235.1.387 Boehringer Ingelheim Investigational Site	North Dartmouth	Massachusetts
United States	1235.1.377 Boehringer Ingelheim Investigational Site	Northport	New York
United States	1235.1.456 Boehringer Ingelheim Investigational Site	Odessa	Texas
United States	1235.1.359 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1235.1.361 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1235.1.436 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1235.1.448 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1235.1.352 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1235.1.369 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1235.1.397 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1235.1.428 Boehringer Ingelheim Investigational Site	Penndel	Pennsylvania
United States	1235.1.449 Boehringer Ingelheim Investigational Site	Pensacola	Florida
United States	1235.1.418 Boehringer Ingelheim Investigational Site	Plano	Texas
United States	1235.1.439 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1235.1.440 Boehringer Ingelheim Investigational Site	Portland	Oregon
United States	1235.1.376 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	1235.1.392 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	1235.1.441 Boehringer Ingelheim Investigational Site	Riverside	California
United States	1235.1.427 Boehringer Ingelheim Investigational Site	Rochester	New York
United States	1235.1.355 Boehringer Ingelheim Investigational Site	Rockledge	Florida
United States	1235.1.409 Boehringer Ingelheim Investigational Site	Sacramento	California
United States	1235.1.358 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	1235.1.464 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	1235.1.406 Boehringer Ingelheim Investigational Site	San Diego	California
United States	1235.1.414 Boehringer Ingelheim Investigational Site	Santa Ana	California
United States	1235.1.382 Boehringer Ingelheim Investigational Site	Selmer	Tennessee
United States	1235.1.412 Boehringer Ingelheim Investigational Site	South Bend	Indiana
United States	1235.1.383 Boehringer Ingelheim Investigational Site	Spring Valley	California
United States	1235.1.434 Boehringer Ingelheim Investigational Site	Stratford	New Jersey
United States	1235.1.371 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1235.1.407 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	1235.1.420 Boehringer Ingelheim Investigational Site	Tempe	Arizona
United States	1235.1.380 Boehringer Ingelheim Investigational Site	Tucker	Georgia
United States	1235.1.386 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	1235.1.395 Boehringer Ingelheim Investigational Site	Tustin	California
United States	1235.1.462 Boehringer Ingelheim Investigational Site	Union	South Carolina
United States	1235.1.455 Boehringer Ingelheim Investigational Site	Waco	Texas
United States	1235.1.356 Boehringer Ingelheim Investigational Site	Wichita	Kansas
United States	1235.1.381 Boehringer Ingelheim Investigational Site	Williamsville	New York
United States	1235.1.384 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina
United States	1235.1.458 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Mexico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP	Observed results for key combination therapies	Baseline to nominal week over the trial	No
Other	BP Control	Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Other	Change From Baseline in Seated Trough Cuff DBP	Observed results for mod-sev patients - key combination therapies	Nominal week over the trial	No
Other	BP Control	Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)	Observed results	Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)	Observed results	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)	Observed results	End-of-study visit (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)	Observed results	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)	Observed results	Up to 8 weeks (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Up to 8 weeks (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)	Observed results	Up to 8 weeks (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Up to 8 weeks (LOCF)	No
Primary	Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.	Baseline to end-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	DBP Control	DBP control is defined as DBP < 90 mmHg - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	DBP Response	DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	SBP Response	SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	BP Normality	No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough; - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline in ABPM 24-hour Mean DBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Change From Baseline in ABPM 24-hour Mean SBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)	No
Secondary	Orthostatic Change in Trough Cuff Mean DBP	Calculated as seated minus standing for all patients - key combination therapies	Week 8	No
Secondary	Orthostatic Change in Trough Cuff Mean SBP	Calculated as seated minus standing for all patients - key combination therapies	Week 8	No
Secondary	Change From Baseline in Seated Trough Pulse Rate	Observed results for all patients - key combination therapies	End-of-study visit (LOCF)	No
Secondary	Change From Baseline in Seated Trough Cuff Mean SBP	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline in Standing Trough Cuff Mean DBP	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline in Standing Trough Cuff Mean SBP	Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.	Up to 8 weeks (LOCF)	No
Secondary	DBP Control	DBP control is defined as DBP < 90 mmHg - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	DBP Response	DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	SBP Response	SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	BP Normality	No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough; - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline in ABPM 24-hour Mean DBP	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	Change From Baseline in ABPM 24-hour Mean SBP	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	Orthostatic Change in Trough Cuff Mean DBP	Calculated as seated minus standing for mod-sev patients - key combination therapies	Week 8	No
Secondary	Orthostatic Change in Trough Cuff Mean SBP	Calculated as seated minus standing for mod-sev patients - key combination therapies	Week 8	No
Secondary	Change From Baseline in Seated Trough Pulse Rate	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)	No
Secondary	Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)	Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).	8 weeks	No

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