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

February 10, 2014 updated by: Boehringer Ingelheim

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1461

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: End-of-study visit (LOCF)
Observed results
End-of-study visit (LOCF)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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)
Time Frame: Up to 8 weeks (LOCF)
Observed results
Up to 8 weeks (LOCF)
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
Time Frame: Up to 8 weeks (LOCF)
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)
Time Frame: Up to 8 weeks (LOCF)
Observed results
Up to 8 weeks (LOCF)
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
Time Frame: Up to 8 weeks (LOCF)
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)
Time Frame: Up to 8 weeks (LOCF)
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)
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
DBP control is defined as DBP < 90 mmHg - key combination therapies
End-of-study (up to 8 weeks) visit (LOCF)
DBP Response
Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: End-of-study (up to 8 weeks) visit (LOCF)

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

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
Time Frame: Up to 8 weeks (LOCF)
Observed results for mod-sev patients - key combination therapies
Up to 8 weeks (LOCF)
Change From Baseline in ABPM 24-hour Mean DBP
Time Frame: Up to 8 weeks (LOCF)
Observed results for mod-sev patients - key combination therapies
Up to 8 weeks (LOCF)
Change From Baseline in ABPM 24-hour Mean SBP
Time Frame: Up to 8 weeks (LOCF)
Observed results for mod-sev patients - key combination therapies
Up to 8 weeks (LOCF)
Orthostatic Change in Trough Cuff Mean DBP
Time Frame: Week 8
Calculated as seated minus standing for mod-sev patients - key combination therapies
Week 8
Orthostatic Change in Trough Cuff Mean SBP
Time Frame: Week 8
Calculated as seated minus standing for mod-sev patients - key combination therapies
Week 8
Change From Baseline in Seated Trough Pulse Rate
Time Frame: Up to 8 weeks (LOCF)
Observed results for mod-sev patients - key combination therapies
Up to 8 weeks (LOCF)
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Time Frame: 8 weeks
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
Time Frame: Baseline to nominal week over the trial
Observed results for key combination therapies
Baseline to nominal week over the trial
BP Control
Time Frame: End-of-study (up to 8 weeks) visit (LOCF)
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
Time Frame: Nominal week over the trial
Observed results for mod-sev patients - key combination therapies
Nominal week over the trial
BP Control
Time Frame: Up to 8 weeks (LOCF)
Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies
Up to 8 weeks (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 1235.1
  • 2008-000874-19 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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