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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00281580
First received: January 24, 2006
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Amlodipine 5 mg
Drug: Placebo
Drug: Telmisartan 20 mg
Drug: Telmisartan 40 mg
Drug: Amlodipine 10 mg
Drug: Telmisartan 80 mg
Drug: Amlodipine 2.5 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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)) ] [ Designated as safety issue: No ]
    Observed results

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    Observed results

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: End-of-study visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    Observed results

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • DBP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    DBP control is defined as DBP < 90 mmHg - key combination therapies

  • DBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies

  • SBP Response [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies

  • BP Normality [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]

    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


  • Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results - key combination therapies

  • Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results - key combination therapies

  • Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results - key combination therapies

  • Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results - key combination therapies

  • Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Calculated as seated minus standing for all patients - key combination therapies

  • Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Calculated as seated minus standing for all patients - key combination therapies

  • Change From Baseline in Seated Trough Pulse Rate [ Time Frame: End-of-study visit (LOCF) ] [ Designated as safety issue: No ]
    Observed results for all patients - key combination therapies

  • Change From Baseline in Seated Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Standing Trough Cuff Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Standing Trough Cuff Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    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.

  • DBP Control [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    DBP control is defined as DBP < 90 mmHg - key combination therapies

  • DBP Response [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies

  • SBP Response [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies

  • BP Normality [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]

    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


  • Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results for mod-sev patients - key combination therapies

  • Change From Baseline in ABPM 24-hour Mean DBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results for mod-sev patients - key combination therapies

  • Change From Baseline in ABPM 24-hour Mean SBP [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results for mod-sev patients - key combination therapies

  • Orthostatic Change in Trough Cuff Mean DBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Calculated as seated minus standing for mod-sev patients - key combination therapies

  • Orthostatic Change in Trough Cuff Mean SBP [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Calculated as seated minus standing for mod-sev patients - key combination therapies

  • Change From Baseline in Seated Trough Pulse Rate [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Observed results for mod-sev patients - key combination therapies

  • Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP [ Time Frame: Baseline to nominal week over the trial ] [ Designated as safety issue: No ]
    Observed results for key combination therapies

  • BP Control [ Time Frame: End-of-study (up to 8 weeks) visit (LOCF) ] [ Designated as safety issue: No ]
    Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies

  • Change From Baseline in Seated Trough Cuff DBP [ Time Frame: Nominal week over the trial ] [ Designated as safety issue: No ]
    Observed results for mod-sev patients - key combination therapies

  • BP Control [ Time Frame: Up to 8 weeks (LOCF) ] [ Designated as safety issue: No ]
    Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies


Enrollment: 1461
Study Start Date: April 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 5g once daily for eight 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 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 5mg once daily for eight weeks
Experimental: Telmisartan 20 / Amlodipine 10
Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily 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
Experimental: Telmisartan 40 / Amlodipine 2.5
Telmisartan 40 / Amlodipine 2.5 for eight weeks
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight weeks
Experimental: Telmisartan 40 / Amlodipine 5
Telmisartan 40 / Amlodipine 5 for eight weeks
Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for eight weeks
Drug: Telmisartan 40 mg
Telmisartan 40 mg once daily for eight 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 10 mg
Amlodipine 10 mg once daily for six weeks
Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
Experimental: Telmisartan 80 / Amlodipine 2.5
Telmisartan 80 / Amlodipine 2.5 for eight weeks
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg once daily for eight weeks
Drug: Telmisartan 80 mg
Telmisartan 80 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 eight weeks
Experimental: Telmisartan 80 / Amlodipine 10
Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Drug: Amlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
Drug: Telmisartan 80 mg
Telmisartan 80 mg once daily for eight weeks
Drug: Amlodipine 10 mg
Amlodipine 10 mg once daily for six weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281580

  Hide Study Locations
Locations
United States, Alabama
1235.1.457 Boehringer Ingelheim Investigational Site
Fairhope, Alabama, United States
1235.1.411 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
1235.1.389 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
1235.1.368 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
United States, Arizona
1235.1.429 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1235.1.420 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
United States, California
1235.1.391 Boehringer Ingelheim Investigational Site
Cudahy, California, United States
1235.1.444 Boehringer Ingelheim Investigational Site
Encinitas, California, United States
1235.1.445 Boehringer Ingelheim Investigational Site
Encino, California, United States
1235.1.357 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1235.1.465 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1235.1.441 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1235.1.409 Boehringer Ingelheim Investigational Site
Sacramento, California, 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
1235.1.383 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
1235.1.395 Boehringer Ingelheim Investigational Site
Tustin, California, United States
United States, Connecticut
1235.1.453 Boehringer Ingelheim Investigational Site
Milford, Connecticut, United States
United States, Delaware
1235.1.394 Boehringer Ingelheim Investigational Site
Newark, Delaware, United States
United States, Florida
1235.1.354 Boehringer Ingelheim Investigational Site
Cooper City, Florida, United States
1235.1.451 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
1235.1.396 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1235.1.372 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1235.1.390 Boehringer Ingelheim Investigational Site
Hialeah, Florida, United States
1235.1.430 Boehringer Ingelheim Investigational Site
Kissimmee, Florida, United States
1235.1.398 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1235.1.351 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1235.1.405 Boehringer Ingelheim Investigational Site
Mirimar, Florida, United States
1235.1.397 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1235.1.369 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1235.1.352 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1235.1.449 Boehringer Ingelheim Investigational Site
Pensacola, Florida, United States
1235.1.355 Boehringer Ingelheim Investigational Site
Rockledge, Florida, United States
1235.1.407 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Georgia
1235.1.380 Boehringer Ingelheim Investigational Site
Tucker, Georgia, United States
United States, Illinois
1235.1.438 Boehringer Ingelheim Investigational Site
Gurnee, Illinois, United States
United States, Indiana
1235.1.373 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1235.1.375 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1235.1.415 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
1235.1.412 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
United States, Kansas
1235.1.435 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas, United States
1235.1.379 Boehringer Ingelheim Investigational Site
Lenexa, Kansas, United States
1235.1.421 Boehringer Ingelheim Investigational Site
Newtown, Kansas, United States
1235.1.356 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Kentucky
1235.1.423 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Massachusetts
1235.1.387 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
United States, Michigan
1235.1.424 Boehringer Ingelheim Investigational Site
Bay City, Michigan, United States
United States, Missouri
1235.1.452 Boehringer Ingelheim Investigational Site
Florissant, Missouri, United States
1235.1.385 Boehringer Ingelheim Investigational Site
Florissant, Missouri, United States
1235.1.431 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
1235.1.365 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
United States, Nevada
1235.1.454 Boehringer Ingelheim Investigational Site
Henderson, Nevada, United States
United States, New Jersey
1235.1.426 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
1235.1.434 Boehringer Ingelheim Investigational Site
Stratford, New Jersey, United States
United States, New York
1235.1.366 Boehringer Ingelheim Investigational Site
East Syracuse, New York, United States
1235.1.377 Boehringer Ingelheim Investigational Site
Northport, New York, United States
1235.1.427 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
1235.1.381 Boehringer Ingelheim Investigational Site
Williamsville, New York, United States
United States, North Carolina
1235.1.410 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1235.1.400 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1235.1.422 Boehringer Ingelheim Investigational Site
Greenboro, North Carolina, United States
1235.1.403 Boehringer Ingelheim Investigational Site
Lenior, North Carolina, United States
1235.1.392 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1235.1.376 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, 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, United States
United States, Ohio
1235.1.446 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1235.1.374 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1235.1.413 Boehringer Ingelheim Investigational Site
Marion, Ohio, United States
United States, Oklahoma
1235.1.448 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.436 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.361 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.359 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.386 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
United States, Oregon
1235.1.440 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1235.1.439 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
1235.1.408 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania, United States
1235.1.404 Boehringer Ingelheim Investigational Site
Lansdale, Pennsylvania, United States
1235.1.428 Boehringer Ingelheim Investigational Site
Penndel, Pennsylvania, United States
United States, Rhode Island
1235.1.370 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
United States, South Carolina
1235.1.433 Boehringer Ingelheim Investigational Site
Beaufort, South Carolina, United States
1235.1.462 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
United States, Tennessee
1235.1.417 Boehringer Ingelheim Investigational Site
Cordova, Tennessee, United States
1235.1.459 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States
1235.1.363 Boehringer Ingelheim Investigational Site
New Tazewell, Tennessee, United States
1235.1.382 Boehringer Ingelheim Investigational Site
Selmer, Tennessee, United States
United States, Texas
1235.1.442 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1235.1.399 Boehringer Ingelheim Investigational Site
Carrollton, Texas, United States
1235.1.460 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1235.1.443 Boehringer Ingelheim Investigational Site
Georgetown, Texas, United States
1235.1.416 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1235.1.402 Boehringer Ingelheim Investigational Site
Lake Jackson, Texas, United States
1235.1.432 Boehringer Ingelheim Investigational Site
McKinney, Texas, United States
1235.1.456 Boehringer Ingelheim Investigational Site
Odessa, Texas, United States
1235.1.418 Boehringer Ingelheim Investigational Site
Plano, Texas, United States
1235.1.455 Boehringer Ingelheim Investigational Site
Waco, Texas, United States
United States, Utah
1235.1.464 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
1235.1.358 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
United States, Virginia
1235.1.437 Boehringer Ingelheim Investigational Site
Burke, Virginia, United States
1235.1.447 Boehringer Ingelheim Investigational Site
Fredericksburg, Virginia, United States
United States, Washington
1235.1.371 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Argentina
1235.1.001 Boehringer Ingelheim Investigational Site
BsAs, Argentina
1235.1.004 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1235.1.006 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1235.1.005 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, Argentina
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, Brazil
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, Mexico
South Africa
1235.1.314 Boehringer Ingelheim Investigational Site
Benoni, South Africa
1235.1.302 Boehringer Ingelheim Investigational Site
Boksburg, South Africa
1235.1.309 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.311 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.310 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.306 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.304 Boehringer Ingelheim Investigational Site
Durban, South Africa
1235.1.313 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1235.1.312 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1235.1.307 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
1235.1.305 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1235.1.303 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1235.1.308 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
1235.1.301 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00281580     History of Changes
Other Study ID Numbers: 1235.1, 2008-000874-19
Study First Received: January 24, 2006
Results First Received: November 18, 2009
Last Updated: February 10, 2014
Health Authority: Argentina:
Brazil:
Mexico:
South Africa:
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 28, 2014