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
2 other identifiers
interventional
1,461
5 countries
136
Brief Summary
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
136 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedResults Posted
Study results publicly available
April 28, 2010
CompletedMarch 27, 2014
February 1, 2014
11 months
January 24, 2006
November 18, 2009
February 10, 2014
Conditions
Outcome Measures
Primary Outcomes (14)
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 Outcomes (28)
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
Baseline to end-of-study (up to 8 weeks) visit (LOCF)
DBP Control
End-of-study (up to 8 weeks) visit (LOCF)
DBP Response
End-of-study (up to 8 weeks) visit (LOCF)
- +23 more secondary outcomes
Other Outcomes (4)
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Baseline to nominal week over the trial
BP Control
End-of-study (up to 8 weeks) visit (LOCF)
Change From Baseline in Seated Trough Cuff DBP
Nominal week over the trial
- +1 more other outcomes
Study Arms (16)
Placebo
PLACEBO COMPARATORPlacebo once daily for eight weeks
Telmisartan 20 mg
EXPERIMENTALTelmisartan 20 mg once daily for eight weeks
Telmisartan 40 mg
EXPERIMENTALTelmisartan 40 mg once daily for eight weeks
Telmisartan 80 mg
EXPERIMENTALTelmisartan 80 mg once daily for eight weeks
Amlodipine 2.5 mg
EXPERIMENTALAmlodipine 2.5 mg once daily for eight weeks
Amlodipine 5 mg
EXPERIMENTALAmlodipine 5 mg once daily for eight weeks
Amlodipine 10 mg
ACTIVE COMPARATORAmlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily
Telmisartan 20 / Amlodipine 2.5
EXPERIMENTALTelmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks
Telmisartan 20 / Amlodipine 5
EXPERIMENTALTelmisartan 20 / Amlodipine 5 mg once daily for eight weeks
Telmisartan 20 / Amlodipine 10
EXPERIMENTALTelmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Telmisartan 40 / Amlodipine 2.5
EXPERIMENTALTelmisartan 40 / Amlodipine 2.5 for eight weeks
Telmisartan 40 / Amlodipine 5
EXPERIMENTALTelmisartan 40 / Amlodipine 5 for eight weeks
Telmisartan 40 / Amlodipine 10
EXPERIMENTALTelmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Telmisartan 80 / Amlodipine 2.5
EXPERIMENTALTelmisartan 80 / Amlodipine 2.5 for eight weeks
Telmisartan 80 / Amlodipine 5
EXPERIMENTALTelmisartan 80 / Amlodipine 5 mg for eight weeks
Telmisartan 80 / Amlodipine 10
EXPERIMENTALTelmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (136)
1235.1.457 Boehringer Ingelheim Investigational Site
Fairhope, 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
Huntsville, Alabama, United States
1235.1.429 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1235.1.420 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
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
1235.1.453 Boehringer Ingelheim Investigational Site
Milford, Connecticut, United States
1235.1.394 Boehringer Ingelheim Investigational Site
Newark, Delaware, United States
1235.1.354 Boehringer Ingelheim Investigational Site
Cooper City, Florida, United States
1235.1.451 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1235.1.372 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1235.1.396 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
1235.1.351 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1235.1.398 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1235.1.405 Boehringer Ingelheim Investigational Site
Mirimar, 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
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
1235.1.380 Boehringer Ingelheim Investigational Site
Tucker, Georgia, United States
1235.1.438 Boehringer Ingelheim Investigational Site
Gurnee, Illinois, United States
1235.1.373 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1235.1.375 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
1235.1.415 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
1235.1.412 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
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
1235.1.423 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
1235.1.387 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1235.1.424 Boehringer Ingelheim Investigational Site
Bay City, Michigan, United States
1235.1.385 Boehringer Ingelheim Investigational Site
Florissant, Missouri, United States
1235.1.452 Boehringer Ingelheim Investigational Site
Florissant, Missouri, United States
1235.1.365 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
1235.1.431 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
1235.1.454 Boehringer Ingelheim Investigational Site
Henderson, Nevada, United States
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
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
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
1235.1.376 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1235.1.392 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
1235.1.374 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1235.1.446 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1235.1.413 Boehringer Ingelheim Investigational Site
Marion, Ohio, United States
1235.1.359 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.361 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.436 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.448 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1235.1.386 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
1235.1.439 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1235.1.440 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1235.1.408 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
1235.1.370 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
1235.1.433 Boehringer Ingelheim Investigational Site
Beaufort, South Carolina, United States
1235.1.462 Boehringer Ingelheim Investigational Site
Union, South Carolina, United States
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
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
1235.1.358 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
1235.1.464 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
1235.1.437 Boehringer Ingelheim Investigational Site
Burke, Virginia, United States
1235.1.447 Boehringer Ingelheim Investigational Site
Fredericksburg, Virginia, United States
1235.1.371 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
1235.1.001 Boehringer Ingelheim Investigational Site
BsAs, Argentina
1235.1.004 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1235.1.005 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1235.1.006 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1235.1.002 Boehringer Ingelheim Investigational Site
Carlos Paz, Argentina
1235.1.003 Boehringer Ingelheim Investigational Site
Córdoba, Argentina
1235.1.115 Universidade Federal do Pará
Belém, Brazil
1235.1.102 Liga de Hipertensão Arterial
Goiânia, 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
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
1235.1.208 "Ignacio Chávez"
Mexico City, Mexico
1235.1.211 Obesidad Y Prevencion de Enfermedades
Mexico City, Mexico
1235.1.212 en Factores de riesgo cardiovascular
México, Mexico
1235.1.205 Fraccionamiento Industrias
San Luis Potosí City, Mexico
1235.1.207
Zapopan, Jalisco, Mexico
1235.1.314 Boehringer Ingelheim Investigational Site
Benoni, South Africa
1235.1.302 Boehringer Ingelheim Investigational Site
Boksburg, South Africa
1235.1.306 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.309 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.310 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.311 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1235.1.304 Boehringer Ingelheim Investigational Site
Durban, South Africa
1235.1.312 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1235.1.313 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1235.1.307 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
1235.1.303 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1235.1.305 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
1235.1.301 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
1235.1.308 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
April 1, 2006
Primary Completion
March 1, 2007
Last Updated
March 27, 2014
Results First Posted
April 28, 2010
Record last verified: 2014-02