HypertensionPhase 3NCT00281580

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

A Phase 3 study testing Amlodipine 5 mg, Telmisartan 20 mg and Telmisartan 40 mg in people with Hypertension, run by Boehringer Ingelheim at 136 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Amlodipine 5 mg, Telmisartan 20 mg and Telmisartan 40 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,461 participants
Where: 136 sitesin 5 countries
Study dates: Apr 2006to Mar 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

136 sites in 5 countries.

Country

City, postcode or hospital

136 sites in 5 countries

United States101 sites

1235.1.435 Boehringer Ingelheim Investigational Site
Arkansas City, Kansas
1235.1.442 Boehringer Ingelheim Investigational Site
Austin, Texas
1235.1.424 Boehringer Ingelheim Investigational Site
Bay City, Michigan
1235.1.433 Boehringer Ingelheim Investigational Site
Beaufort, South Carolina
1235.1.437 Boehringer Ingelheim Investigational Site
Burke, Virginia
1235.1.410 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
1235.1.399 Boehringer Ingelheim Investigational Site
Carrollton, Texas
1235.1.429 Boehringer Ingelheim Investigational Site
Chandler, Arizona
1235.1.400 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1235.1.426 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey
1235.1.374 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1235.1.446 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1235.1.354 Boehringer Ingelheim Investigational Site
Cooper City, Florida
1235.1.417 Boehringer Ingelheim Investigational Site
Cordova, Tennessee
1235.1.391 Boehringer Ingelheim Investigational Site
Cudahy, California
1235.1.460 Boehringer Ingelheim Investigational Site
Dallas, Texas
1235.1.451 Boehringer Ingelheim Investigational Site
DeLand, Florida
1235.1.370 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island
1235.1.366 Boehringer Ingelheim Investigational Site
East Syracuse, New York
1235.1.444 Boehringer Ingelheim Investigational Site
Encinitas, California
1235.1.445 Boehringer Ingelheim Investigational Site
Encino, California
1235.1.408 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
1235.1.373 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1235.1.375 Boehringer Ingelheim Investigational Site
Evansville, Indiana
1235.1.457 Boehringer Ingelheim Investigational Site
Fairhope, Alabama
1235.1.385 Boehringer Ingelheim Investigational Site
Florissant, Missouri
1235.1.452 Boehringer Ingelheim Investigational Site
Florissant, Missouri
1235.1.372 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1235.1.396 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1235.1.447 Boehringer Ingelheim Investigational Site
Fredericksburg, Virginia
1235.1.443 Boehringer Ingelheim Investigational Site
Georgetown, Texas
1235.1.422 Boehringer Ingelheim Investigational Site
Greenboro, North Carolina
1235.1.438 Boehringer Ingelheim Investigational Site
Gurnee, Illinois
1235.1.454 Boehringer Ingelheim Investigational Site
Henderson, Nevada
1235.1.390 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1235.1.368 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1235.1.389 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1235.1.411 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1235.1.415 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1235.1.459 Boehringer Ingelheim Investigational Site
Jackson, Tennessee
1235.1.365 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1235.1.431 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
1235.1.416 Boehringer Ingelheim Investigational Site
Killeen, Texas
1235.1.430 Boehringer Ingelheim Investigational Site
Kissimmee, Florida
1235.1.402 Boehringer Ingelheim Investigational Site
Lake Jackson, Texas
1235.1.404 Boehringer Ingelheim Investigational Site
Lansdale, Pennsylvania
1235.1.379 Boehringer Ingelheim Investigational Site
Lenexa, Kansas
1235.1.403 Boehringer Ingelheim Investigational Site
Lenior, North Carolina
1235.1.357 Boehringer Ingelheim Investigational Site
Long Beach, California
1235.1.465 Boehringer Ingelheim Investigational Site
Los Angeles, California
1235.1.423 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1235.1.413 Boehringer Ingelheim Investigational Site
Marion, Ohio
1235.1.432 Boehringer Ingelheim Investigational Site
McKinney, Texas
1235.1.351 Boehringer Ingelheim Investigational Site
Melbourne, Florida
1235.1.398 Boehringer Ingelheim Investigational Site
Melbourne, Florida
1235.1.453 Boehringer Ingelheim Investigational Site
Milford, Connecticut
1235.1.405 Boehringer Ingelheim Investigational Site
Mirimar, Florida
1235.1.363 Boehringer Ingelheim Investigational Site
New Tazewell, Tennessee
1235.1.394 Boehringer Ingelheim Investigational Site
Newark, Delaware
1235.1.421 Boehringer Ingelheim Investigational Site
Newtown, Kansas
1235.1.387 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1235.1.377 Boehringer Ingelheim Investigational Site
Northport, New York
1235.1.456 Boehringer Ingelheim Investigational Site
Odessa, Texas
1235.1.359 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1235.1.361 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1235.1.436 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1235.1.448 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1235.1.352 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1235.1.369 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1235.1.397 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
1235.1.428 Boehringer Ingelheim Investigational Site
Penndel, Pennsylvania
1235.1.449 Boehringer Ingelheim Investigational Site
Pensacola, Florida
1235.1.418 Boehringer Ingelheim Investigational Site
Plano, Texas
1235.1.439 Boehringer Ingelheim Investigational Site
Portland, Oregon
1235.1.440 Boehringer Ingelheim Investigational Site
Portland, Oregon
1235.1.376 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1235.1.392 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1235.1.441 Boehringer Ingelheim Investigational Site
Riverside, California
1235.1.427 Boehringer Ingelheim Investigational Site
Rochester, New York
1235.1.355 Boehringer Ingelheim Investigational Site
Rockledge, Florida
1235.1.409 Boehringer Ingelheim Investigational Site
Sacramento, California
1235.1.358 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1235.1.464 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
1235.1.406 Boehringer Ingelheim Investigational Site
San Diego, California
1235.1.414 Boehringer Ingelheim Investigational Site
Santa Ana, California
1235.1.382 Boehringer Ingelheim Investigational Site
Selmer, Tennessee
1235.1.412 Boehringer Ingelheim Investigational Site
South Bend, Indiana
1235.1.383 Boehringer Ingelheim Investigational Site
Spring Valley, California
1235.1.434 Boehringer Ingelheim Investigational Site
Stratford, New Jersey
1235.1.371 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1235.1.407 Boehringer Ingelheim Investigational Site
Tampa, Florida
1235.1.420 Boehringer Ingelheim Investigational Site
Tempe, Arizona
1235.1.380 Boehringer Ingelheim Investigational Site
Tucker, Georgia
1235.1.386 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
1235.1.395 Boehringer Ingelheim Investigational Site
Tustin, California
1235.1.462 Boehringer Ingelheim Investigational Site
Union, South Carolina
1235.1.455 Boehringer Ingelheim Investigational Site
Waco, Texas
1235.1.356 Boehringer Ingelheim Investigational Site
Wichita, Kansas
1235.1.381 Boehringer Ingelheim Investigational Site
Williamsville, New York
1235.1.384 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
1235.1.458 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

South Africa14 sites

1235.1.314 Boehringer Ingelheim Investigational Site
Benoni
1235.1.302 Boehringer Ingelheim Investigational Site
Boksburg
1235.1.306 Boehringer Ingelheim Investigational Site
Cape Town
1235.1.309 Boehringer Ingelheim Investigational Site
Cape Town
1235.1.310 Boehringer Ingelheim Investigational Site
Cape Town
1235.1.311 Boehringer Ingelheim Investigational Site
Cape Town
1235.1.304 Boehringer Ingelheim Investigational Site
Durban
1235.1.312 Boehringer Ingelheim Investigational Site
Johannesburg
1235.1.313 Boehringer Ingelheim Investigational Site
Johannesburg
1235.1.307 Boehringer Ingelheim Investigational Site
Krugersdorp
1235.1.303 Boehringer Ingelheim Investigational Site
Lenasia
1235.1.305 Boehringer Ingelheim Investigational Site
Lenasia
1235.1.301 Boehringer Ingelheim Investigational Site
Pretoria
1235.1.308 Boehringer Ingelheim Investigational Site
Pretoria

Other trials in South Africa

Mexico10 sites

1235.1.203
Col. Magdalena de Las Salinas
1235.1.210 Consultorio Privado
Durango, Durango
1235.1.202
Guadalajara, Jalisco
1235.1.209 Boehringer Ingelheim Investigational Site
Guadalajara, Jalisco
1235.1.204
Lomas de Guevara, Guadalajara
1235.1.212 en Factores de riesgo cardiovascular
México
1235.1.208 "Ignacio Chávez"
Mexico City
1235.1.211 Obesidad Y Prevencion de Enfermedades
Mexico City
1235.1.205 Fraccionamiento Industrias
San Luis Potosí City
1235.1.207
Zapopan, Jalisco

Other trials in Mexico

Argentina6 sites

1235.1.001 Boehringer Ingelheim Investigational Site
BsAs
1235.1.004 Boehringer Ingelheim Investigational Site
Buenos Aires
1235.1.005 Boehringer Ingelheim Investigational Site
Buenos Aires
1235.1.006 Boehringer Ingelheim Investigational Site
Buenos Aires
1235.1.002 Boehringer Ingelheim Investigational Site
Carlos Paz
1235.1.003 Boehringer Ingelheim Investigational Site
Córdoba

Other trials in Argentina

Brazil5 sites

1235.1.115 Universidade Federal do Pará
Belém
1235.1.102 Liga de Hipertensão Arterial
Goiânia
1235.1.101 Clínica Médica
Rio de Janeiro
1235.1.103 Unidade de Hipertensão - ICHC -
São Paulo
1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão
São Paulo

Other trials in Brazil

About this study

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

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

Conditions: Hypertension
Being tested: Amlodipine 5 mg, Placebo, Telmisartan 20 mg, Telmisartan 40 mg, Amlodipine 10 mg
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00281580
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo once daily for eight weeks Receives: Drug: Placebo
Telmisartan 20 mg	Experimental	Telmisartan 20 mg once daily for eight weeks Receives: Drug: Telmisartan 20 mg
Telmisartan 40 mg	Experimental	Telmisartan 40 mg once daily for eight weeks Receives: Drug: Telmisartan 40 mg
Telmisartan 80 mg	Experimental	Telmisartan 80 mg once daily for eight weeks Receives: Drug: Telmisartan 80 mg
Amlodipine 2.5 mg	Experimental	Amlodipine 2.5 mg once daily for eight weeks Receives: Drug: Amlodipine 2.5 mg
Amlodipine 5 mg	Experimental	Amlodipine 5 mg once daily for eight weeks Receives: Drug: Amlodipine 5 mg
Amlodipine 10 mg	Active comparator	Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily Receives: Drug: Amlodipine 5 mg; Drug: Amlodipine 10 mg
Telmisartan 20 / Amlodipine 2.5	Experimental	Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks Receives: Drug: Telmisartan 20 mg; Drug: Amlodipine 2.5 mg
Telmisartan 20 / Amlodipine 5	Experimental	Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks Receives: Drug: Telmisartan 20 mg; Drug: Amlodipine 5 mg
Telmisartan 20 / Amlodipine 10	Experimental	Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks Receives: Drug: Amlodipine 10 mg; Drug: Telmisartan 20 mg; Drug: Amlodipine 5 mg
Telmisartan 40 / Amlodipine 2.5	Experimental	Telmisartan 40 / Amlodipine 2.5 for eight weeks Receives: Drug: Amlodipine 2.5 mg; Drug: Telmisartan 40 mg
Telmisartan 40 / Amlodipine 5	Experimental	Telmisartan 40 / Amlodipine 5 for eight weeks Receives: Drug: Amlodipine 5 mg; Drug: Telmisartan 40 mg
Telmisartan 40 / Amlodipine 10	Experimental	Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks Receives: Drug: Telmisartan 40 mg; Drug: Amlodipine 10 mg; Drug: Amlodipine 5 mg
Telmisartan 80 / Amlodipine 2.5	Experimental	Telmisartan 80 / Amlodipine 2.5 for eight weeks Receives: Drug: Amlodipine 2.5 mg; Drug: Telmisartan 80 mg
Telmisartan 80 / Amlodipine 5	Experimental	Telmisartan 80 / Amlodipine 5 mg for eight weeks Receives: Drug: Telmisartan 80 mg; Drug: Amlodipine 5 mg
Telmisartan 80 / Amlodipine 10	Experimental	Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks Receives: Drug: Amlodipine 5 mg; Drug: Telmisartan 80 mg; Drug: Amlodipine 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
Observed results
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 8 weeks (LOCF)
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
Observed results
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks (LOCF)

Secondary outcomes (28)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Mar 2007

First posted25 Jan 2006 (estimated)
Study startApr 2006
Primary completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Enrolment: 1,461 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00281580
Sponsor's protocol ID: 1235.1
Other IDs: 2008-000874-19, 2008
Status last verified: Feb 2014
First submitted: 24 Jan 2006
Last updated: 27 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00281580
Acronym / sponsor ID: 1235.1
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,461 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Mar 2007 (actual)
First posted: 25 Jan 2006 (estimated)
Results: Posted 28 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Number of arms: 16

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo once daily for eight weeks
Telmisartan 20 mg	Experimental	Drug: Telmisartan 20 mgTelmisartan 20 mg once daily for eight weeks
Telmisartan 40 mg	Experimental	Drug: Telmisartan 40 mgTelmisartan 40 mg once daily for eight weeks
Telmisartan 80 mg	Experimental	Drug: Telmisartan 80 mgTelmisartan 80 mg once daily for eight weeks
Amlodipine 2.5 mg	Experimental	Drug: Amlodipine 2.5 mgAmlodipine 2.5 mg once daily for eight weeks
Amlodipine 5 mg	Experimental	Drug: Amlodipine 5 mgAmlodipine 5 mg once daily for eight weeks
Amlodipine 10 mg	Active comparator	Drug: Amlodipine 5 mg, Drug: Amlodipine 10 mgAmlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily
Telmisartan 20 / Amlodipine 2.5	Experimental	Drug: Telmisartan 20 mg, Drug: Amlodipine 2.5 mgTelmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks
Telmisartan 20 / Amlodipine 5	Experimental	Drug: Telmisartan 20 mg, Drug: Amlodipine 5 mgTelmisartan 20 / Amlodipine 5 mg once daily for eight weeks
Telmisartan 20 / Amlodipine 10	Experimental	Drug: Amlodipine 10 mg, Drug: Telmisartan 20 mg, Drug: Amlodipine 5 mgTelmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Telmisartan 40 / Amlodipine 2.5	Experimental	Drug: Amlodipine 2.5 mg, Drug: Telmisartan 40 mgTelmisartan 40 / Amlodipine 2.5 for eight weeks
Telmisartan 40 / Amlodipine 5	Experimental	Drug: Amlodipine 5 mg, Drug: Telmisartan 40 mgTelmisartan 40 / Amlodipine 5 for eight weeks
Telmisartan 40 / Amlodipine 10	Experimental	Drug: Telmisartan 40 mg, Drug: Amlodipine 10 mg, Drug: Amlodipine 5 mgTelmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks
Telmisartan 80 / Amlodipine 2.5	Experimental	Drug: Amlodipine 2.5 mg, Drug: Telmisartan 80 mgTelmisartan 80 / Amlodipine 2.5 for eight weeks
Telmisartan 80 / Amlodipine 5	Experimental	Drug: Telmisartan 80 mg, Drug: Amlodipine 5 mgTelmisartan 80 / Amlodipine 5 mg for eight weeks
Telmisartan 80 / Amlodipine 10	Experimental	Drug: Amlodipine 5 mg, Drug: Telmisartan 80 mg, Drug: Amlodipine 10 mgTelmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine 5 mgAmlodipine 5 mg once daily for two weeks	Drug	Telmisartan 80 / Amlodipine 10
PlaceboPlacebo to Telmisartan and Amlodipine once daily for eight weeks	Drug	Placebo
Telmisartan 20 mgTelmisartan 20 mg once daily for eight weeks	Drug	Telmisartan 20 mg
Telmisartan 40 mgTelmisartan 40 mg once daily for eight weeks	Drug	Telmisartan 40 / Amlodipine 10
Amlodipine 10 mgAmlodipine 10 mg once daily for six weeks	Drug	Telmisartan 20 / Amlodipine 10
Telmisartan 20 mgTelmisartan 20 mg once daily for eight weeks	Drug	Telmisartan 20 / Amlodipine 2.5
Telmisartan 80 mgTelmisartan 80 mg once daily for eight weeks	Drug	Telmisartan 80 / Amlodipine 10
Amlodipine 10 mgAmlodipine 10 mg once daily for six weeks	Drug	Telmisartan 80 / Amlodipine 10
Telmisartan 20 mgTelmisartan 20 mg once daily for eight weeks	Drug	Telmisartan 20 / Amlodipine 10
Amlodipine 5 mgAmlodipine 5 mg once daily for two weeks	Drug	Telmisartan 20 / Amlodipine 10
Amlodipine 5 mgamlodipine 5g once daily for eight weeks	Drug	Amlodipine 5 mg
Telmisartan 20 mgTelmisartan 20 mg once daily for eight weeks	Drug	Telmisartan 20 / Amlodipine 5
Amlodipine 5 mgAmlodipine 5 mg once daily for eight weeks	Drug	Telmisartan 40 / Amlodipine 5
Amlodipine 5 mgamlodipine 5mg once daily for eight weeks	Drug	Telmisartan 20 / Amlodipine 5
Amlodipine 2.5 mgAmlodipine 2.5 mg once daily for eight weeks	Drug	Amlodipine 2.5 mg
Amlodipine 2.5 mgAmlodipine 2.5 mg once daily for eight weeks	Drug	Telmisartan 80 / Amlodipine 2.5
Amlodipine 10 mgAmlodipine 10 mg once daily for six weeks	Drug	Telmisartan 40 / Amlodipine 10
Amlodipine 2.5 mgAmlodipine 2.5 mg once daily for eight weeks	Drug	Telmisartan 40 / Amlodipine 2.5
Telmisartan 80 mgTelmisartan 80 mg once daily for eight weeks	Drug	Telmisartan 80 mg
Telmisartan 80 mgTelmisartan 80 mg once daily for eight weeks	Drug	Telmisartan 80 / Amlodipine 5
Amlodipine 5 mgAmlodipine 5 mg once daily for two weeks	Drug	Telmisartan 40 / Amlodipine 10
Amlodipine 2.5 mgAmlodipine 2.5 mg once daily for eight weeks	Drug	Telmisartan 20 / Amlodipine 2.5
Telmisartan 40 mgTelmisartan 40 mg once daily for eight weeks	Drug	Telmisartan 40 / Amlodipine 2.5
Telmisartan 40 mgTelmisartan 40 mg once daily for eight weeks	Drug	Telmisartan 40 / Amlodipine 5
Amlodipine 5 mgamlodipine 5g once daily for two weeks	Drug	Amlodipine 10 mg
Amlodipine 5 mgAmlodipine 5 mg once daily for eight weeks	Drug	Telmisartan 80 / Amlodipine 5
Telmisartan 40 mgTelmisartan 40 mg once daily for eight weeks	Drug	Telmisartan 40 mg
Telmisartan 80 mgTelmisartan 80 mg once daily for eight weeks	Drug	Telmisartan 80 / Amlodipine 2.5
Amlodipine 10 mgAmlodipine 10 mg once daily for six weeks	Drug	Amlodipine 10 mg

Primary outcome

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
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.
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
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.
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
Time frame: End-of-study visit (LOCF)
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)
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)
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)
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)
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)
Observed results
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.
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
Time frame: Up to 8 weeks (LOCF)
Observed results
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.
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.

28 secondary outcomes

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)
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)
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)
DBP Control
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
DBP Response
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
SBP Response
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
BP Normality
Time frame: 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)
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Time frame: 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)
Change From Baseline in ABPM 24-hour Mean SBP
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Orthostatic Change in Trough Cuff Mean DBP
Time frame: Week 8
Orthostatic Change in Trough Cuff Mean SBP
Time frame: Week 8
Change From Baseline in Seated Trough Pulse Rate
Time frame: End-of-study visit (LOCF)
Change From Baseline in Seated Trough Cuff Mean SBP
Time frame: Up to 8 weeks (LOCF)
Change From Baseline in Standing Trough Cuff Mean DBP
Time frame: Up to 8 weeks (LOCF)
Change From Baseline in Standing Trough Cuff Mean SBP
Time frame: Up to 8 weeks (LOCF)
DBP Control
Time frame: Up to 8 weeks (LOCF)
DBP Response
Time frame: Up to 8 weeks (LOCF)
SBP Response
Time frame: Up to 8 weeks (LOCF)
BP Normality
Time frame: Up to 8 weeks (LOCF)
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Time frame: Up to 8 weeks (LOCF)
Change From Baseline in ABPM 24-hour Mean DBP
Time frame: Up to 8 weeks (LOCF)
Change From Baseline in ABPM 24-hour Mean SBP
Time frame: Up to 8 weeks (LOCF)
Orthostatic Change in Trough Cuff Mean DBP
Time frame: Week 8
Orthostatic Change in Trough Cuff Mean SBP
Time frame: Week 8
Change From Baseline in Seated Trough Pulse Rate
Time frame: Up to 8 weeks (LOCF)
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Time frame: 8 weeks

Results and safety

Results posted to the registry on 28 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Pl)	46	39
Telmisartan 20 mg (T20)	42	41
Telmisartan 40 mg (T40)	130	125
Telmisartan 80 mg (T80)	135	118
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)	44	40
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)	46	43
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)	44	39
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)	47	46
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)	143	135
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)	129	117
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)	48	44
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)	146	136
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)	142	129
Amlodipine 2.5 mg (A2.5)	50	43
Amlodipine 5 mg (A5)	140	133
Amlodipine 10 mg (A10)	129	116

Primary outcome: 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)). Mean (Standard Deviation). Unit: mmHg

Measure	Telmisartan 0 mg (T0) n = 355	Telmisartan 20 mg (T20) n = 171	Telmisartan 40 mg (T40) n = 440	Telmisartan 80 mg (T80) n = 457
Value	-13 (8.8)	-16.4 (7.8)	-16.2 (8.9)	-16.9 (8.6)

Population analysed: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).

Primary outcome: 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). Least squares mean (Standard Error). Unit: mmHg

Measure	Telmisartan 0 mg (T0) n = 355	Telmisartan 20 mg (T20) n = 171	Telmisartan 40 mg (T40) n = 440	Telmisartan 80 mg (T80) n = 457
Value	-12.5 (0.5)	-16.8 (0.6)	-16.6 (0.4)	-17.2 (0.4)

Primary outcome: 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). Mean (Standard Deviation). Unit: mmHg

Measure	Placebo (Pl) n = 349	Amlodipine 2.5 mg (A2.5) n = 185	Amlodipine 5 mg (A5) n = 466	Amlodipine 10 mg (A10) n = 423
Value	-12.3 (9.7)	-14.9 (8.8)	-15.6 (8.1)	-18.6 (7.7)

Primary outcome: 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). Least squares mean (Standard Error). Unit: mmHg

Measure	Placebo (Pl) n = 349	Amlodipine 2.5 mg (A2.5) n = 185	Amlodipine 5 mg (A5) n = 466	Amlodipine 10 mg (A10) n = 423
Value	-12.2 (0.5)	-15.3 (0.6)	-16.2 (0.4)	-19.3 (0.4)

28 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO	0 of 46 (0%)	6 of ?	Not reported
Telmisartan 20 mg (T20)	0 of 42 (0%)	5 of ?	Not reported
Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)	0 of 44 (0%)	4 of ?	Not reported
Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)	0 of 46 (0%)	5 of ?	Not reported
Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)	0 of 44 (0%)	6 of ?	Not reported
Telmisartan 40 mg (T40)	0 of 130 (0%)	13 of ?	Not reported
Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)	0 of 47 (0%)	3 of ?	Not reported
Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)	0 of 143 (0%)	9 of ?	Not reported
Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)	0 of 129 (0%)	13 of ?	Not reported
Telmisartan 80 mg (T80)	1 of 135 (0.7%)	5 of ?	Not reported
Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)	2 of 48 (4.2%)	1 of ?	Not reported
Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)	2 of 146 (1.4%)	10 of ?	Not reported
Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)	0 of 142 (0%)	23 of ?	Not reported
Amlodipine 2.5 mg (A2.5)	1 of 50 (2%)	2 of ?	Not reported
Amlodipine 5 mg (A5)	1 of 140 (0.7%)	10 of ?	Not reported
Amlodipine 10 mg (A10)	0 of 129 (0%)	29 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

136 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine 5 mg, Telmisartan 20 mg and Telmisartan 40 mg in people with Hypertension, run by Boehringer Ingelheim at 136 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, South Africa, Mexico, Argentina, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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))). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.