Clinical trial NCT00281593: Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 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: 1354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.


Eligibility criteria: 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:

* Pregnant
* breast-feeding
* unwilling to use birth control during the study
* secondary hypertension
* SBP\>=180 mmHg
* DBP\>=120 mmHg
* severe renal dysfunction
* hepatic insufficiency
* stroke within the last 6 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
* history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.

Primary outcomes:
measure: Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM
Other outcomes:
Locations:
city: Glendale
country: United States
facility: 1236.1.511 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tempe
country: United States
facility: 1236.1.574 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 1236.1.501 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 1236.1.557 Boehringer Ingelheim Investigational Site
state: Arizona
city: Buena Park
country: United States
facility: 1236.1.523 Boehringer Ingelheim Investigational Site
state: California
city: Concord
country: United States
facility: 1236.1.514 Boehringer Ingelheim Investigational Site
state: California
city: Encinitas
country: United States
facility: 1236.1.560 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1236.1.573 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1236.1.516 Boehringer Ingelheim Investigational Site
state: California
city: Roseville
country: United States
facility: 1236.1.529 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1236.1.519 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 1236.1.543 Boehringer Ingelheim Investigational Site
state: California
city: Boulder
country: United States
facility: 1236.1.528 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 1236.1.530 Boehringer Ingelheim Investigational Site
state: Connecticut
city: DeLand
country: United States
facility: 1236.1.572 Boehringer Ingelheim Investigational Site
state: Florida
city: Hialeah
country: United States
facility: 1236.1.577 Boehringer Ingelheim Investigational Site
state: Florida
city: Jupiter
country: United States
facility: 1236.1.526 Boehringer Ingelheim Investigational Site
state: Florida
city: Largo
country: United States
facility: 1236.1.527 Boehringer Ingelheim Investigational Site
state: Florida
city: Naples
country: United States
facility: 1236.1.503 Anchor Research Center
state: Florida
city: New Port Richey
country: United States
facility: 1236.1.520 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1236.1.571 Boehringer Ingelheim Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: 1236.1.565 Boehringer Ingelheim Investigational Site
state: Georgia
city: Meridian
country: United States
facility: 1236.1.538 Boehringer Ingelheim Investigational Site
state: Idaho
city: Peoria
country: United States
facility: 1236.1.532 Boehringer Ingelheim Investigational Site
state: Illinois
city: Avon
country: United States
facility: 1236.1.553 Boehringer Ingelheim Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: 1236.1.546 River Cities Cardiology Research Inst of Middle America
state: Indiana
city: Valparaiso
country: United States
facility: 1236.1.563 Boehringer Ingelheim Investigational Site
state: Indiana
city: Newton
country: United States
facility: 1236.1.517 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 1236.1.531 Boehringer Ingelheim Investigational Site
state: Kansas
city: Richmond
country: United States
facility: 1236.1.566 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Auburn
country: United States
facility: 1236.1.551 Boehringer Ingelheim Investigational Site
state: Maine
city: Haverhill
country: United States
facility: 1236.1.536 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: 1236.1.576 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: West Yarmouth
country: United States
facility: 1236.1.561 Clinical Research Center of Cape Cod
state: Massachusetts
city: Cadillac
country: United States
facility: 1236.1.555 Boehringer Ingelheim Investigational Site
state: Michigan
city: Troy
country: United States
facility: 1236.1.509 Boehringer Ingelheim Investigational Site
state: Michigan
city: Excelsior Springs
country: United States
facility: 1236.1.541 Boehringer Ingelheim Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: 1236.1.556 Boehringer Ingelheim Investigational Site
state: Nevada
city: Toms River
country: United States
facility: 1236.1.525 Physicians Research Center, LLC, Toms River
state: New Jersey
city: Albuquerque
country: United States
facility: 1236.1.508 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: 1236.1.522 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: 1236.1.542 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Cincinnati
country: United States
facility: 1236.1.547 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1236.1.567 Boehringer Ingelheim Investigational Site
state: Ohio
city: Kettering
country: United States
facility: 1236.1.515 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 1236.1.575 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Corvallis
country: United States
facility: 1236.1.554 Boehringer Ingelheim Investigational Site
state: Oregon
city: Eugene
country: United States
facility: 1236.1.524 Boehringer Ingelheim Investigational Site
state: Oregon
city: Medford
country: United States
facility: 1236.1.544 Boehringer Ingelheim Investigational Site
state: Oregon
city: Portland
country: United States
facility: 1236.1.545 Boehringer Ingelheim Investigational Site
state: Oregon
city: Erie
country: United States
facility: 1236.1.569 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Harleysville
country: United States
facility: 1236.1.505 Ledeeach Family Medicine
state: Pennsylvania
city: Tipton
country: United States
facility: 1236.1.564 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Cumberland
country: United States
facility: 1236.1.534 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Spartanburg
country: United States
facility: 1236.1.539 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Carrollton
country: United States
facility: 1236.1.568 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1236.1.549 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1236.1.559 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1236.1.548 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1236.1.550 Boehringer Ingelheim Investigational Site
state: Texas
city: The Colony
country: United States
facility: 1236.1.570 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 1236.1.510 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 1236.1.513 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 1236.1.521 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 1236.1.512 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 1236.1.535 Boehringer Ingelheim Investigational Site
state: Utah
city: Falls Church
country: United States
facility: 1236.1.502 Boehringer Ingelheim Investigational Site
state: Virginia
city: Madison
country: United States
facility: 1236.1.504 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: 1236.1.540 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Menomonee Falls
country: United States
facility: 1236.1.562 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Buenos aIRES
country: Argentina
facility: 1236.1.601 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1236.1.604 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1236.1.605 Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: 1236.1.610
city: Buenos Aires
country: Argentina
facility: 1236.1.612
city: Capital Federal,Buenos Aires
country: Argentina
facility: 1236.1.619
city: Capital Federal
country: Argentina
facility: 1236.1.608
city: Capital Federal
country: Argentina
facility: 1236.1.618 Hospital Ramos Mejia
city: CordobaCordoba
country: Argentina
facility: 1236.1.615
city: Cordoba
country: Argentina
facility: 1236.1.603 Boehringer Ingelheim Investigational Site
city: Corrientes
country: Argentina
facility: 1236.1.611
city: Córdoba
country: Argentina
facility: 1236.1.606
city: Córdoba
country: Argentina
facility: 1236.1.613
city: Córdoba
country: Argentina
facility: 1236.1.614
city: Derqui
country: Argentina
facility: 1236.1.609
city: Mar Del Plata
country: Argentina
facility: 1236.1.624 Instituto de Investigaciones Clínicas
city: Ramos Mejía
country: Argentina
facility: 1236.1.620 DIM - Clinica Privada
city: Salta
country: Argentina
facility: 1236.1.622 Hospital San Bernardo
city: Santa Fe
country: Argentina
facility: 1236.1.621 Clinica del Torax y Especialidades
city: vILLA carlos paz
country: Argentina
facility: 1236.1.602 Boehringer Ingelheim Investigational Site
city: Zárate
country: Argentina
facility: 1236.1.616
city: Coquitlam
country: Canada
facility: 1236.1.202 North Road Medical Centre
state: British Columbia
city: Bay Roberts
country: Canada
facility: 1236.1.208 Shoppers Drug Mart Building
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: 1236.1.206 77 Commonwealth Avenue
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1236.1.215 Cowan Avenue Medical Clinic
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 1236.1.203 MSHJ Research Associates
state: Nova Scotia
city: Hamilton
country: Canada
facility: 1236.1.210 Hamilton Medical Research
state: Ontario
city: Kitchener
country: Canada
facility: 1236.1.204 Dr. Ivan Jagas
state: Ontario
city: Ottawa
country: Canada
facility: 1236.1.209 St. Joseph Cardiovascular Inc
state: Ontario
city: Sarnia
country: Canada
facility: 1236.1.207 Dr. Michael O'Mahony
state: Ontario
city: Sainte-Foy
country: Canada
facility: 1236.1.205 Ctr. Hospital U Quebec- Pav CHUL
state: Quebec
city: Saskatoon
country: Canada
facility: 1236.1.211 Royal University Hospital
state: Saskatchewan
city: Puente Alto, Santiago De Chile
country: Chile
facility: 1236.1.106 Hospital Dr. Sótero del Río
city: Santiago de Chile
country: Chile
facility: 1236.1.103 Oficina 312 E (Cardiology Division)
city: Acapulco Guerrero
country: Mexico
facility: 1236.1.301 Fracc. Magallanes
city: Aguascalientes
country: Mexico
facility: 1236.1.304 Fracc Agricultura
city: Aguascalientes
country: Mexico
facility: 1236.1.311 Hospital de Especialidades Miguel Hidalgo
city: Col Ciudad De Sol Zapopan
country: Mexico
facility: 1236.1.305 Especialidades Médicas del sol
city: Col. Magdalena De Las Salinas
country: Mexico
facility: 1236.1.310 Departamento de Hemodinamia
city: Guadalajara
country: Mexico
facility: 1236.1.307 Consultorio: Aurelio L
city: México D.F
country: Mexico
facility: 1236.1.306
city: San Luis Potosí
country: Mexico
facility: 1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto"
city: Torreón,
country: Mexico
facility: 1236.1.302
city: Veracruz
country: Mexico
facility: 1236.1.303
city: Bella Vista, Callao,
country: Peru
facility: 1236.1.401 Unidad de Investigacion
city: San Borja.
country: Peru
facility: 1236.1.405
city: San Isidro.
country: Peru
facility: 1236.1.403
city: San Isidro
country: Peru
facility: 1236.1.402
city: San Isidro
country: Peru
facility: 1236.1.404
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: