Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

NCT00281593 | Completed Phase 3

• 1 other identifier: 1236.1
• Study Type: interventional
• Target: 1,354
• Locations: 6 countries
• Sites: 119

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary Outcomes (1)

• 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

Interventions

Telmisartan DRUG

Ramipril DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (119)

1236.1.511 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Location

1236.1.574 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

1236.1.501 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

1236.1.557 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

1236.1.523 Boehringer Ingelheim Investigational Site

Buena Park, California, United States

Location

1236.1.514 Boehringer Ingelheim Investigational Site

Concord, California, United States

Location

1236.1.560 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

1236.1.573 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1236.1.516 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1236.1.529 Boehringer Ingelheim Investigational Site

Roseville, California, United States

Location

1236.1.519 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1236.1.543 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

1236.1.528 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

1236.1.530 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

1236.1.572 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1236.1.577 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1236.1.526 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Location

1236.1.527 Boehringer Ingelheim Investigational Site

Largo, Florida, United States

Location

1236.1.503 Anchor Research Center

Naples, Florida, United States

Location

1236.1.520 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Location

1236.1.571 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1236.1.565 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Location

1236.1.538 Boehringer Ingelheim Investigational Site

Meridian, Idaho, United States

Location

1236.1.532 Boehringer Ingelheim Investigational Site

Peoria, Illinois, United States

Location

1236.1.553 Boehringer Ingelheim Investigational Site

Avon, Indiana, United States

Location

1236.1.546 River Cities Cardiology Research Inst of Middle America

Jeffersonville, Indiana, United States

Location

1236.1.563 Boehringer Ingelheim Investigational Site

Valparaiso, Indiana, United States

Location

1236.1.517 Boehringer Ingelheim Investigational Site

Newton, Kansas, United States

Location

1236.1.531 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1236.1.566 Boehringer Ingelheim Investigational Site

Richmond, Kentucky, United States

Location

1236.1.551 Boehringer Ingelheim Investigational Site

Auburn, Maine, United States

Location

1236.1.536 Boehringer Ingelheim Investigational Site

Haverhill, Massachusetts, United States

Location

1236.1.576 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1236.1.561 Clinical Research Center of Cape Cod

West Yarmouth, Massachusetts, United States

Location

1236.1.555 Boehringer Ingelheim Investigational Site

Cadillac, Michigan, United States

Location

1236.1.509 Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Location

1236.1.541 Boehringer Ingelheim Investigational Site

Excelsior Springs, Missouri, United States

Location

1236.1.556 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1236.1.525 Physicians Research Center, LLC, Toms River

Toms River, New Jersey, United States

Location

1236.1.508 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1236.1.522 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1236.1.542 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1236.1.547 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1236.1.567 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1236.1.515 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Location

1236.1.575 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1236.1.554 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Location

1236.1.524 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

1236.1.544 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1236.1.545 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1236.1.569 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

1236.1.505 Ledeeach Family Medicine

Harleysville, Pennsylvania, United States

Location

1236.1.564 Boehringer Ingelheim Investigational Site

Tipton, Pennsylvania, United States

Location

1236.1.534 Boehringer Ingelheim Investigational Site

Cumberland, Rhode Island, United States

Location

1236.1.539 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1236.1.568 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

1236.1.549 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1236.1.559 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1236.1.548 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1236.1.550 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1236.1.570 Boehringer Ingelheim Investigational Site

The Colony, Texas, United States

Location

1236.1.510 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1236.1.513 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1236.1.521 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1236.1.512 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

1236.1.535 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

1236.1.502 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

Location

1236.1.504 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

1236.1.540 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

1236.1.562 Boehringer Ingelheim Investigational Site

Menomonee Falls, Wisconsin, United States

Location

1236.1.601 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1236.1.604 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1236.1.605 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1236.1.610

Buenos Aires, Argentina

Location

1236.1.612

Buenos Aires, Argentina

Location

1236.1.619

Capital Federal,Buenos Aires, Argentina

Location

1236.1.608

Capital Federal, Argentina

Location

1236.1.618 Hospital Ramos Mejia

Capital Federal, Argentina

Location

1236.1.615

CordobaCordoba, Argentina

Location

1236.1.611

Corrientes, Argentina

Location

1236.1.603 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Location

1236.1.606

Córdoba, Argentina

Location

1236.1.613

Córdoba, Argentina

Location

1236.1.614

Córdoba, Argentina

Location

1236.1.624 Instituto de Investigaciones Clínicas

Mar del Plata, Argentina

Location

1236.1.609

Presidente Derqui, Argentina

Location

1236.1.620 DIM - Clinica Privada

Ramos Mejía, Argentina

Location

1236.1.622 Hospital San Bernardo

Salta, Argentina

Location

1236.1.621 Clinica del Torax y Especialidades

Santa Fe, Argentina

Location

1236.1.602 Boehringer Ingelheim Investigational Site

Villa Carlos Paz, Argentina

Location

1236.1.616

Zárate, Argentina

Location

1236.1.202 North Road Medical Centre

Coquitlam, British Columbia, Canada

Location

1236.1.208 Shoppers Drug Mart Building

Bay Roberts, Newfoundland and Labrador, Canada

Location

1236.1.206 77 Commonwealth Avenue

Mount Pearl, Newfoundland and Labrador, Canada

Location

1236.1.215 Cowan Avenue Medical Clinic

St. John's, Newfoundland and Labrador, Canada

Location

1236.1.203 MSHJ Research Associates

Halifax, Nova Scotia, Canada

Location

1236.1.210 Hamilton Medical Research

Hamilton, Ontario, Canada

Location

1236.1.204 Dr. Ivan Jagas

Kitchener, Ontario, Canada

Location

1236.1.209 St. Joseph Cardiovascular Inc

Ottawa, Ontario, Canada

Location

1236.1.207 Dr. Michael O'Mahony

Sarnia, Ontario, Canada

Location

1236.1.205 Ctr. Hospital U Quebec- Pav CHUL

Sainte-Foy, Quebec, Canada

Location

1236.1.211 Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

1236.1.106 Hospital Dr. Sótero del Río

Puente Alto, Santiago de Chile, Chile

Location

1236.1.103 Oficina 312 E (Cardiology Division)

Santiago, Chile

Location

1236.1.301 Fracc. Magallanes

Acapulco Guerrero, Mexico

Location

1236.1.304 Fracc Agricultura

Aguascalientes, Mexico

Location

1236.1.311 Hospital de Especialidades Miguel Hidalgo

Aguascalientes, Mexico

Location

1236.1.305 Especialidades Médicas del sol

Col Ciudad de Sol Zapopan, Mexico

Location

1236.1.310 Departamento de Hemodinamia

Col. Magdalena de Las Salinas, Mexico

Location

1236.1.307 Consultorio: Aurelio L

Guadalajara, Mexico

Location

1236.1.306

México D.F, Mexico

Location

1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, Mexico

Location

1236.1.302

Torreón, Mexico

Location

1236.1.303

Veracruz, Mexico

Location

1236.1.401 Unidad de Investigacion

Bella Vista, Callao,, Peru

Location

1236.1.405

San Borja, Peru

Location

1236.1.402

San Isidro, Peru

Location

1236.1.403

San Isidro, Peru

Location

1236.1.404

San Isidro, Peru

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Ramipril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

US (70); AR (21); ME (10); PE (5); CA (11); CL (2)