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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Telmisartan 20 mg; Drug: Telmisartan 40 mg; Drug: Telmisartan 80 mg; Drug: Amlodipine 2.5 mg; Drug: Amlodipine 5 mg; Drug: Amlodipine 5 mg; Drug: Amlodipine 5 mg; Drug: Amlodipine 5 mg; Drug: Amlodipine 5 mg; Drug: Amlodipine 10 mg

• Study Type: Interventional
• Enrollment (Actual): 1461
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo once daily for eight weeks	Drug: Placebo; Placebo to Telmisartan and Amlodipine once daily for eight weeks
Experimental: Telmisartan 20 mg; Telmisartan 20 mg once daily for eight weeks	Drug: Telmisartan 20 mg; Telmisartan 20 mg once daily for eight weeks
Experimental: Telmisartan 40 mg; Telmisartan 40 mg once daily for eight weeks	Drug: Telmisartan 40 mg; Telmisartan 40 mg once daily for eight weeks
Experimental: Telmisartan 80 mg; Telmisartan 80 mg once daily for eight weeks	Drug: Telmisartan 80 mg; Telmisartan 80 mg once daily for eight weeks
Experimental: Amlodipine 2.5 mg; Amlodipine 2.5 mg once daily for eight weeks	Drug: Amlodipine 2.5 mg; Amlodipine 2.5 mg once daily for eight weeks
Experimental: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks	Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks
Active Comparator: Amlodipine 10 mg; Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily	Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks; Drug: Amlodipine 10 mg; Amlodipine 10 mg once daily for six weeks
Experimental: Telmisartan 20 / Amlodipine 2.5; Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks	Drug: Telmisartan 20 mg; Telmisartan 20 mg once daily for eight weeks; Drug: Amlodipine 2.5 mg; Amlodipine 2.5 mg once daily for eight weeks
Experimental: Telmisartan 20 / Amlodipine 5; Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks	Drug: Telmisartan 20 mg; Telmisartan 20 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks
Experimental: Telmisartan 20 / Amlodipine 10; Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks	Drug: Telmisartan 20 mg; Telmisartan 20 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks; Drug: Amlodipine 10 mg; Amlodipine 10 mg once daily for six weeks
Experimental: Telmisartan 40 / Amlodipine 2.5; Telmisartan 40 / Amlodipine 2.5 for eight weeks	Drug: Telmisartan 40 mg; Telmisartan 40 mg once daily for eight weeks; Drug: Amlodipine 2.5 mg; Amlodipine 2.5 mg once daily for eight weeks
Experimental: Telmisartan 40 / Amlodipine 5; Telmisartan 40 / Amlodipine 5 for eight weeks	Drug: Telmisartan 40 mg; Telmisartan 40 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks
Experimental: Telmisartan 40 / Amlodipine 10; Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks	Drug: Telmisartan 40 mg; Telmisartan 40 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks; Drug: Amlodipine 10 mg; Amlodipine 10 mg once daily for six weeks
Experimental: Telmisartan 80 / Amlodipine 2.5; Telmisartan 80 / Amlodipine 2.5 for eight weeks	Drug: Telmisartan 80 mg; Telmisartan 80 mg once daily for eight weeks; Drug: Amlodipine 2.5 mg; Amlodipine 2.5 mg once daily for eight weeks
Experimental: Telmisartan 80 / Amlodipine 5; Telmisartan 80 / Amlodipine 5 mg for eight weeks	Drug: Telmisartan 80 mg; Telmisartan 80 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks
Experimental: Telmisartan 80 / Amlodipine 10; Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks	Drug: Telmisartan 80 mg; Telmisartan 80 mg once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for two weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for eight weeks; Drug: Amlodipine 5 mg; Amlodipine 5 mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5mg once daily for eight weeks; Drug: Amlodipine 5 mg; amlodipine 5g once daily for two weeks; Drug: Amlodipine 10 mg; Amlodipine 10 mg once daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))
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)
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)
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)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)	Observed results	End-of-study visit (LOCF)
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)
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)
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)
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)
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)	Observed results	Up to 8 weeks (LOCF)
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)
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)	Observed results	Up to 8 weeks (LOCF)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
DBP Control	DBP control is defined as DBP < 90 mmHg - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)
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)
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)
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)
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)
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)
Change From Baseline in ABPM 24-hour Mean DBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)
Change From Baseline in ABPM 24-hour Mean SBP	Observed results - key combination therapies	End-of-study (up to 8 weeks) visit (LOCF)
Orthostatic Change in Trough Cuff Mean DBP	Calculated as seated minus standing for all patients - key combination therapies	Week 8
Orthostatic Change in Trough Cuff Mean SBP	Calculated as seated minus standing for all patients - key combination therapies	Week 8
Change From Baseline in Seated Trough Pulse Rate	Observed results for all patients - key combination therapies	End-of-study visit (LOCF)
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)
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)
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)
DBP Control	DBP control is defined as DBP < 90 mmHg - key combination therapies	Up to 8 weeks (LOCF)
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)
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)
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)
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)
Change From Baseline in ABPM 24-hour Mean DBP	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)
Change From Baseline in ABPM 24-hour Mean SBP	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)
Orthostatic Change in Trough Cuff Mean DBP	Calculated as seated minus standing for mod-sev patients - key combination therapies	Week 8
Orthostatic Change in Trough Cuff Mean SBP	Calculated as seated minus standing for mod-sev patients - key combination therapies	Week 8
Change From Baseline in Seated Trough Pulse Rate	Observed results for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Change From Baseline in Seated Trough Cuff DBP	Observed results for mod-sev patients - key combination therapies	Nominal week over the trial
BP Control	Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies	Up to 8 weeks (LOCF)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: January 24, 2006
• First Submitted That Met QC Criteria: January 24, 2006
• First Posted (Estimate): January 25, 2006

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan
• Other Study ID Numbers: 1235.1; 2008-000874-19 (EudraCT Number: EudraCT)