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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00281593
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Study Start: 2006-04
• Primary Completion: 2007-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1354

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (119)

1236.1.573 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1236.1.560 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

1236.1.523 Boehringer Ingelheim Investigational Site; 🇺🇸 Buena Park, California, United States

1236.1.529 Boehringer Ingelheim Investigational Site; 🇺🇸 Roseville, California, United States

1236.1.543 Boehringer Ingelheim Investigational Site; 🇺🇸 Westlake Village, California, United States

1236.1.528 Boehringer Ingelheim Investigational Site; 🇺🇸 Boulder, Colorado, United States

1236.1.572 Boehringer Ingelheim Investigational Site; 🇺🇸 DeLand, Florida, United States

1236.1.577 Boehringer Ingelheim Investigational Site; 🇺🇸 Hialeah, Florida, United States

1236.1.526 Boehringer Ingelheim Investigational Site; 🇺🇸 Jupiter, Florida, United States

1236.1.527 Boehringer Ingelheim Investigational Site; 🇺🇸 Largo, Florida, United States

1236.1.503 Anchor Research Center; 🇺🇸 Naples, Florida, United States

1236.1.565 Boehringer Ingelheim Investigational Site; 🇺🇸 Blue Ridge, Georgia, United States

1236.1.571 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

1236.1.520 Boehringer Ingelheim Investigational Site; 🇺🇸 New Port Richey, Florida, United States

1236.1.532 Boehringer Ingelheim Investigational Site; 🇺🇸 Peoria, Illinois, United States

1236.1.553 Boehringer Ingelheim Investigational Site; 🇺🇸 Avon, Indiana, United States

1236.1.546 River Cities Cardiology Research Inst of Middle America; 🇺🇸 Jeffersonville, Indiana, United States

1236.1.563 Boehringer Ingelheim Investigational Site; 🇺🇸 Valparaiso, Indiana, United States

1236.1.517 Boehringer Ingelheim Investigational Site; 🇺🇸 Newton, Kansas, United States

1236.1.566 Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Kentucky, United States

1236.1.536 Boehringer Ingelheim Investigational Site; 🇺🇸 Haverhill, Massachusetts, United States

1236.1.576 Boehringer Ingelheim Investigational Site; 🇺🇸 North Dartmouth, Massachusetts, United States

1236.1.561 Clinical Research Center of Cape Cod; 🇺🇸 West Yarmouth, Massachusetts, United States

1236.1.555 Boehringer Ingelheim Investigational Site; 🇺🇸 Cadillac, Michigan, United States

1236.1.509 Boehringer Ingelheim Investigational Site; 🇺🇸 Troy, Michigan, United States

1236.1.541 Boehringer Ingelheim Investigational Site; 🇺🇸 Excelsior Springs, Missouri, United States

1236.1.515 Boehringer Ingelheim Investigational Site; 🇺🇸 Kettering, Ohio, United States

1236.1.575 Boehringer Ingelheim Investigational Site; 🇺🇸 Tulsa, Oklahoma, United States

1236.1.554 Boehringer Ingelheim Investigational Site; 🇺🇸 Corvallis, Oregon, United States

1236.1.524 Boehringer Ingelheim Investigational Site; 🇺🇸 Eugene, Oregon, United States

1236.1.544 Boehringer Ingelheim Investigational Site; 🇺🇸 Medford, Oregon, United States

1236.1.569 Boehringer Ingelheim Investigational Site; 🇺🇸 Erie, Pennsylvania, United States

1236.1.505 Ledeeach Family Medicine; 🇺🇸 Harleysville, Pennsylvania, United States

1236.1.564 Boehringer Ingelheim Investigational Site; 🇺🇸 Tipton, Pennsylvania, United States

1236.1.534 Boehringer Ingelheim Investigational Site; 🇺🇸 Cumberland, Rhode Island, United States

1236.1.568 Boehringer Ingelheim Investigational Site; 🇺🇸 Carrollton, Texas, United States

1236.1.570 Boehringer Ingelheim Investigational Site; 🇺🇸 The Colony, Texas, United States

1236.1.502 Boehringer Ingelheim Investigational Site; 🇺🇸 Falls Church, Virginia, United States

1236.1.512 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

1236.1.535 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

1236.1.562 Boehringer Ingelheim Investigational Site; 🇺🇸 Menomonee Falls, Wisconsin, United States

1236.1.609; 🇦🇷 Derqui, Argentina

1236.1.624 Instituto de Investigaciones Clínicas; 🇦🇷 Mar Del Plata, Argentina

1236.1.620 DIM - Clinica Privada; 🇦🇷 Ramos Mejía, Argentina

1236.1.206 77 Commonwealth Avenue; 🇨🇦 Mount Pearl, Newfoundland and Labrador, Canada

1236.1.208 Shoppers Drug Mart Building; 🇨🇦 Bay Roberts, Newfoundland and Labrador, Canada

1236.1.210 Hamilton Medical Research; 🇨🇦 Hamilton, Ontario, Canada

1236.1.204 Dr. Ivan Jagas; 🇨🇦 Kitchener, Ontario, Canada

1236.1.209 St. Joseph Cardiovascular Inc; 🇨🇦 Ottawa, Ontario, Canada

1236.1.207 Dr. Michael O'Mahony; 🇨🇦 Sarnia, Ontario, Canada

1236.1.106 Hospital Dr. Sótero del Río; 🇨🇱 Puente Alto, Santiago De Chile, Chile

1236.1.103 Oficina 312 E (Cardiology Division); 🇨🇱 Santiago de Chile, Chile

1236.1.307 Consultorio: Aurelio L; 🇲🇽 Guadalajara, Mexico

1236.1.306; 🇲🇽 México D.F, Mexico

1236.1.401 Unidad de Investigacion; 🇵🇪 Bella Vista, Callao,, Peru

1236.1.404; 🇵🇪 San Isidro, Peru

1236.1.514 Boehringer Ingelheim Investigational Site; 🇺🇸 Concord, California, United States

1236.1.516 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1236.1.519 Boehringer Ingelheim Investigational Site; 🇺🇸 Tustin, California, United States

1236.1.567 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

1236.1.549 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1236.1.559 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1236.1.501 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1236.1.511 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

1236.1.574 Boehringer Ingelheim Investigational Site; 🇺🇸 Tempe, Arizona, United States

1236.1.557 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1236.1.530 Boehringer Ingelheim Investigational Site; 🇺🇸 Farmington, Connecticut, United States

1236.1.538 Boehringer Ingelheim Investigational Site; 🇺🇸 Meridian, Idaho, United States

1236.1.551 Boehringer Ingelheim Investigational Site; 🇺🇸 Auburn, Maine, United States

1236.1.556 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

1236.1.539 Boehringer Ingelheim Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States

1236.1.601 Boehringer Ingelheim Investigational Site; 🇦🇷 Buenos aIRES, Argentina

1236.1.604 Boehringer Ingelheim Investigational Site; 🇦🇷 Buenos Aires, Argentina

1236.1.605 Boehringer Ingelheim Investigational Site; 🇦🇷 Buenos Aires, Argentina

1236.1.610; 🇦🇷 Buenos Aires, Argentina

1236.1.619; 🇦🇷 Capital Federal,Buenos Aires, Argentina

1236.1.612; 🇦🇷 Buenos Aires, Argentina

1236.1.608; 🇦🇷 Capital Federal, Argentina

1236.1.618 Hospital Ramos Mejia; 🇦🇷 Capital Federal, Argentina

1236.1.615; 🇦🇷 CordobaCordoba, Argentina

1236.1.603 Boehringer Ingelheim Investigational Site; 🇦🇷 Cordoba, Argentina

1236.1.611; 🇦🇷 Corrientes, Argentina

1236.1.606; 🇦🇷 Córdoba, Argentina

1236.1.613; 🇦🇷 Córdoba, Argentina

1236.1.614; 🇦🇷 Córdoba, Argentina

1236.1.622 Hospital San Bernardo; 🇦🇷 Salta, Argentina

1236.1.621 Clinica del Torax y Especialidades; 🇦🇷 Santa Fe, Argentina

1236.1.602 Boehringer Ingelheim Investigational Site; 🇦🇷 vILLA carlos paz, Argentina

1236.1.616; 🇦🇷 Zárate, Argentina

1236.1.202 North Road Medical Centre; 🇨🇦 Coquitlam, British Columbia, Canada

1236.1.203 MSHJ Research Associates; 🇨🇦 Halifax, Nova Scotia, Canada

1236.1.205 Ctr. Hospital U Quebec- Pav CHUL; 🇨🇦 Sainte-Foy, Quebec, Canada

1236.1.301 Fracc. Magallanes; 🇲🇽 Acapulco Guerrero, Mexico

1236.1.304 Fracc Agricultura; 🇲🇽 Aguascalientes, Mexico

1236.1.311 Hospital de Especialidades Miguel Hidalgo; 🇲🇽 Aguascalientes, Mexico

1236.1.305 Especialidades Médicas del sol; 🇲🇽 Col Ciudad De Sol Zapopan, Mexico

1236.1.310 Departamento de Hemodinamia; 🇲🇽 Col. Magdalena De Las Salinas, Mexico

1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosí, Mexico

1236.1.302; 🇲🇽 Torreón,, Mexico

1236.1.303; 🇲🇽 Veracruz, Mexico

1236.1.405; 🇵🇪 San Borja., Peru

1236.1.403; 🇵🇪 San Isidro., Peru

1236.1.402; 🇵🇪 San Isidro, Peru

1236.1.531 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

1236.1.508 Boehringer Ingelheim Investigational Site; 🇺🇸 Albuquerque, New Mexico, United States

1236.1.522 Boehringer Ingelheim Investigational Site; 🇺🇸 Albuquerque, New Mexico, United States

1236.1.542 Boehringer Ingelheim Investigational Site; 🇺🇸 Albuquerque, New Mexico, United States

1236.1.547 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

1236.1.545 Boehringer Ingelheim Investigational Site; 🇺🇸 Portland, Oregon, United States

1236.1.548 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1236.1.550 Boehringer Ingelheim Investigational Site; 🇺🇸 San Antonio, Texas, United States

1236.1.510 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

1236.1.513 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

1236.1.521 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

1236.1.504 Boehringer Ingelheim Investigational Site; 🇺🇸 Madison, Wisconsin, United States

1236.1.540 Boehringer Ingelheim Investigational Site; 🇺🇸 Madison, Wisconsin, United States

1236.1.525 Physicians Research Center, LLC, Toms River; 🇺🇸 Toms River, New Jersey, United States

1236.1.215 Cowan Avenue Medical Clinic; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

1236.1.211 Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada