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

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Ramipril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

To demonstrate that Micardis and Altace when used together are more effective at lowering blood pres sure.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment

Primary outcome: Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- 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

Boehringer Ingelheim Investigational Site, Buenos aIRES, Argentina

Boehringer Ingelheim Investigational Site, vILLA carlos paz, Argentina

Boehringer Ingelheim Investigational Site, Cordoba, Argentina

Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

Boehringer Ingelheim Investigational Site, Derqui, Argentina

Boehringer Ingelheim Investigational Site, Corrientes, Argentina

Boehringer Ingelheim Investigational Site, CordobaCordoba, Argentina

Boehringer Ingelheim Investigational Site, Zarate, Argentina

Hospital Ramos Mejia, Capital Federal, Argentina

Boehringer Ingelheim Investigational Site, Capital Federal,Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Ramos Mejia, Argentina

Boehringer Ingelheim Investigational Site, SANTA FE, Argentina

Hospital San Bernardo, Salta, Argentina

Boehringer Ingelheim Investigational Site, Rosario, Argentina

Boehringer Ingelheim Investigational Site, MAR DEL PLATA, Argentina

Pontificia Universidad Catolica de Chile, Santiago de Chile, Chile

Hospital Dr. Sotero del Rio, Puente Alto, Santiago de Chile, Chile

Fracc. Magallanes, Acapulco Guerrero, Mexico

Boehringer Ingelheim Investigational Site, Torreon,, Mexico

Boehringer Ingelheim Investigational Site, Veracruz, Mexico

Fracc Agricultura, Aguascalientes, Mexico

Boehringer Ingelheim Investigational Site, Col Ciudad de sol Zapopan, Mexico

Boehringer Ingelheim Investigational Site, Mexico D.F, Mexico

Boehringer Ingelheim Investigational Site, Guadalajara, Mexico

Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi, Mexico

Departamento de Hemodinamia, Col. Magdalena de las Salinas, Mexico

Hospital de Especialidades Miguel Hidalgo, Aguascalientes, Mexico

Unidad De Investigacion, Bella Vista, Callao,, Peru

Boehringer Ingelheim Investigational Site, San Isidro, Peru

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Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada

Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, Canada

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MSHJ Research Associates, Halifax, Nova Scotia, Canada

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Ctr. Hospital U Quebec- Pav CHUL, Sainte-Foy, Quebec, Canada

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Royal University Hospital, Saskatoon, Saskatchewan, Canada

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Ending date: October 2007
Last updated: December 18, 2007