Clinical trial NCT00281580: Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 1461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
timeFrame: End-of-study visit (LOCF)
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
timeFrame: Up to 8 weeks (LOCF)
Secondary outcomes:
measure: Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
timeFrame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
measure: DBP Control
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: DBP Response
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: SBP Response
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: BP Normality
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in ABPM 24-hour Mean DBP
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in ABPM 24-hour Mean SBP
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Orthostatic Change in Trough Cuff Mean DBP
timeFrame: Week 8
measure: Orthostatic Change in Trough Cuff Mean SBP
timeFrame: Week 8
measure: Change From Baseline in Seated Trough Pulse Rate
timeFrame: End-of-study visit (LOCF)
measure: Change From Baseline in Seated Trough Cuff Mean SBP
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Standing Trough Cuff Mean DBP
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in Standing Trough Cuff Mean SBP
timeFrame: Up to 8 weeks (LOCF)
measure: DBP Control
timeFrame: Up to 8 weeks (LOCF)
measure: DBP Response
timeFrame: Up to 8 weeks (LOCF)
measure: SBP Response
timeFrame: Up to 8 weeks (LOCF)
measure: BP Normality
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in ABPM 24-hour Mean DBP
timeFrame: Up to 8 weeks (LOCF)
measure: Change From Baseline in ABPM 24-hour Mean SBP
timeFrame: Up to 8 weeks (LOCF)
measure: Orthostatic Change in Trough Cuff Mean DBP
timeFrame: Week 8
measure: Orthostatic Change in Trough Cuff Mean SBP
timeFrame: Week 8
measure: Change From Baseline in Seated Trough Pulse Rate
timeFrame: Up to 8 weeks (LOCF)
measure: Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
timeFrame: 8 weeks
Other outcomes:
measure: Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
timeFrame: Baseline to nominal week over the trial
measure: BP Control
timeFrame: End-of-study (up to 8 weeks) visit (LOCF)
measure: Change From Baseline in Seated Trough Cuff DBP
timeFrame: Nominal week over the trial
measure: BP Control
timeFrame: Up to 8 weeks (LOCF)
Locations:
city: Fairhope
country: United States
facility: 1235.1.457 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 1235.1.368 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 1235.1.389 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 1235.1.411 Boehringer Ingelheim Investigational Site
state: Alabama
city: Chandler
country: United States
facility: 1235.1.429 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tempe
country: United States
facility: 1235.1.420 Boehringer Ingelheim Investigational Site
state: Arizona
city: Cudahy
country: United States
facility: 1235.1.391 Boehringer Ingelheim Investigational Site
state: California
city: Encinitas
country: United States
facility: 1235.1.444 Boehringer Ingelheim Investigational Site
state: California
city: Encino
country: United States
facility: 1235.1.445 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1235.1.357 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1235.1.465 Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: 1235.1.441 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 1235.1.409 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1235.1.406 Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: 1235.1.414 Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: 1235.1.383 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1235.1.395 Boehringer Ingelheim Investigational Site
state: California
city: Milford
country: United States
facility: 1235.1.453 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 1235.1.394 Boehringer Ingelheim Investigational Site
state: Delaware
city: Cooper City
country: United States
facility: 1235.1.354 Boehringer Ingelheim Investigational Site
state: Florida
city: Deland
country: United States
facility: 1235.1.451 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 1235.1.372 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 1235.1.396 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1235.1.390 Boehringer Ingelheim Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: 1235.1.430 Boehringer Ingelheim Investigational Site
state: Florida
city: Melbourne
country: United States
facility: 1235.1.351 Boehringer Ingelheim Investigational Site
state: Florida
city: Melbourne
country: United States
facility: 1235.1.398 Boehringer Ingelheim Investigational Site
state: Florida
city: Mirimar
country: United States
facility: 1235.1.405 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1235.1.352 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1235.1.369 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1235.1.397 Boehringer Ingelheim Investigational Site
state: Florida
city: Pensacola
country: United States
facility: 1235.1.449 Boehringer Ingelheim Investigational Site
state: Florida
city: Rockledge
country: United States
facility: 1235.1.355 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1235.1.407 Boehringer Ingelheim Investigational Site
state: Florida
city: Tucker
country: United States
facility: 1235.1.380 Boehringer Ingelheim Investigational Site
state: Georgia
city: Gurnee
country: United States
facility: 1235.1.438 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 1235.1.373 Boehringer Ingelheim Investigational Site
state: Indiana
city: Evansville
country: United States
facility: 1235.1.375 Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: 1235.1.415 Boehringer Ingelheim Investigational Site
state: Indiana
city: South Bend
country: United States
facility: 1235.1.412 Boehringer Ingelheim Investigational Site
state: Indiana
city: Arkansas City
country: United States
facility: 1235.1.435 Boehringer Ingelheim Investigational Site
state: Kansas
city: Lenexa
country: United States
facility: 1235.1.379 Boehringer Ingelheim Investigational Site
state: Kansas
city: Newtown
country: United States
facility: 1235.1.421 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 1235.1.356 Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: 1235.1.423 Boehringer Ingelheim Investigational Site
state: Kentucky
city: North Dartmouth
country: United States
facility: 1235.1.387 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Bay City
country: United States
facility: 1235.1.424 Boehringer Ingelheim Investigational Site
state: Michigan
city: Florissant
country: United States
facility: 1235.1.385 Boehringer Ingelheim Investigational Site
state: Missouri
city: Florissant
country: United States
facility: 1235.1.452 Boehringer Ingelheim Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: 1235.1.365 Boehringer Ingelheim Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: 1235.1.431 Boehringer Ingelheim Investigational Site
state: Missouri
city: Henderson
country: United States
facility: 1235.1.454 Boehringer Ingelheim Investigational Site
state: Nevada
city: Cherry Hill
country: United States
facility: 1235.1.426 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Stratford
country: United States
facility: 1235.1.434 Boehringer Ingelheim Investigational Site
state: New Jersey
city: East Syracuse
country: United States
facility: 1235.1.366 Boehringer Ingelheim Investigational Site
state: New York
city: Northport
country: United States
facility: 1235.1.377 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 1235.1.427 Boehringer Ingelheim Investigational Site
state: New York
city: Williamsville
country: United States
facility: 1235.1.381 Boehringer Ingelheim Investigational Site
state: New York
city: Burlington
country: United States
facility: 1235.1.410 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 1235.1.400 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Greenboro
country: United States
facility: 1235.1.422 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Lenior
country: United States
facility: 1235.1.403 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 1235.1.376 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 1235.1.392 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1235.1.384 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1235.1.458 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: 1235.1.374 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1235.1.446 Boehringer Ingelheim Investigational Site
state: Ohio
city: Marion
country: United States
facility: 1235.1.413 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1235.1.359 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 1235.1.361 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 1235.1.436 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 1235.1.448 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: 1235.1.386 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: 1235.1.439 Boehringer Ingelheim Investigational Site
state: Oregon
city: Portland
country: United States
facility: 1235.1.440 Boehringer Ingelheim Investigational Site
state: Oregon
city: Erie
country: United States
facility: 1235.1.408 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Lansdale
country: United States
facility: 1235.1.404 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Penndel
country: United States
facility: 1235.1.428 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: 1235.1.370 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Beaufort
country: United States
facility: 1235.1.433 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 1235.1.462 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Cordova
country: United States
facility: 1235.1.417 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: 1235.1.459 Boehringer Ingelheim Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: 1235.1.363 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Selmer
country: United States
facility: 1235.1.382 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 1235.1.442 Boehringer Ingelheim Investigational Site
state: Texas
city: Carrollton
country: United States
facility: 1235.1.399 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1235.1.460 Boehringer Ingelheim Investigational Site
state: Texas
city: Georgetown
country: United States
facility: 1235.1.443 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1235.1.416 Boehringer Ingelheim Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: 1235.1.402 Boehringer Ingelheim Investigational Site
state: Texas
city: McKinney
country: United States
facility: 1235.1.432 Boehringer Ingelheim Investigational Site
state: Texas
city: Odessa
country: United States
facility: 1235.1.456 Boehringer Ingelheim Investigational Site
state: Texas
city: Plano
country: United States
facility: 1235.1.418 Boehringer Ingelheim Investigational Site
state: Texas
city: Waco
country: United States
facility: 1235.1.455 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 1235.1.358 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 1235.1.464 Boehringer Ingelheim Investigational Site
state: Utah
city: Burke
country: United States
facility: 1235.1.437 Boehringer Ingelheim Investigational Site
state: Virginia
city: Fredericksburg
country: United States
facility: 1235.1.447 Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: 1235.1.371 Boehringer Ingelheim Investigational Site
state: Washington
city: BsAs
country: Argentina
facility: 1235.1.001 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1235.1.004 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1235.1.005 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1235.1.006 Boehringer Ingelheim Investigational Site
city: Carlos Paz
country: Argentina
facility: 1235.1.002 Boehringer Ingelheim Investigational Site
city: Cordoba
country: Argentina
facility: 1235.1.003 Boehringer Ingelheim Investigational Site
city: Belém
country: Brazil
facility: 1235.1.115 Universidade Federal do Pará
city: Goiania
country: Brazil
facility: 1235.1.102 Liga de Hipertensão Arterial
city: Rio de Janeiro
country: Brazil
facility: 1235.1.101 Clínica Médica
city: São Paulo
country: Brazil
facility: 1235.1.103 Unidade de Hipertensão - ICHC -
city: São Paulo
country: Brazil
facility: 1235.1.109 Centro de Pesquisas do Hospital do Rim e Hipertensão
city: Col. Magdalena de las Salinas
country: Mexico
facility: 1235.1.203
city: Durango, Durango
country: Mexico
facility: 1235.1.210 Consultorio Privado
city: Guadalajara, Jalisco
country: Mexico
facility: 1235.1.202
city: Guadalajara, Jalisco
country: Mexico
facility: 1235.1.209 Boehringer Ingelheim Investigational Site
city: Lomas de Guevara, Guadalajara
country: Mexico
facility: 1235.1.204
city: mexico DF
country: Mexico
facility: 1235.1.208 "Ignacio Chávez"
city: Mexico, D.F.
country: Mexico
facility: 1235.1.211 Obesidad Y Prevencion de Enfermedades
city: Mexico
country: Mexico
facility: 1235.1.212 en Factores de riesgo cardiovascular
city: San Luis Potosi
country: Mexico
facility: 1235.1.205 Fraccionamiento Industrias
city: Zapopan, Jalisco
country: Mexico
facility: 1235.1.207
city: Benoni
country: South Africa
facility: 1235.1.314 Boehringer Ingelheim Investigational Site
city: Boksburg
country: South Africa
facility: 1235.1.302 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.1.306 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.1.309 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.1.310 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.1.311 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1235.1.304 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.1.312 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.1.313 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1235.1.307 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1235.1.303 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1235.1.305 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1235.1.301 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1235.1.308 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: