Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Amlodipine (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 Norvasc when used together are more effective at lowering blood pressure.

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

Primary outcome: Efficacy: Change from baseline in seated trough cuff diastolic blood pressure after eight weeks of treatment

Secondary outcome: Efficacy: change after 8 wks in: seated cuff SBP; % pts with BP response to treatment; standing DBP and SBP; ABPM overall and hourly BP changes. Safety:AEs, Labs, ECG, Orthostatic BP changes, PR

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, BsAs, Argentina

Boehringer Ingelheim Investigational Site, Carlos Paz, Argentina

Boehringer Ingelheim Investigational Site, Cordoba, Argentina

Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina

Clinica Medica, Rio de Janeiro, Brazil

Liga de Hipertens?o Arterial, Goiania, Brazil

Unidade de Hipertens?o - ICHC -, S?o Paulo, Brazil

Boehringer Ingelheim Investigational Site, S?o Paulo, Brazil

Universidade Federal do Para, Belem, Brazil

Boehringer Ingelheim Investigational Site, Guadalajara, Jalisco, Mexico

Boehringer Ingelheim Investigational Site, Col. Magdalena de las Salinas, Mexico

Boehringer Ingelheim Investigational Site, Lomas de Guevara, Guadalajara, Mexico

Fraccionamiento Industrias, San Luis Potosi, Mexico

Boehringer Ingelheim Investigational Site, Zapopan, Jalisco, Mexico

Boehringer Ingelheim Investigational Site, mexico DF, Mexico

Boehringer Ingelheim Investigational Site, Durango, Durango, Mexico

Boehringer Ingelheim Investigational Site, Mexico, D.F., Mexico

Boehringer Ingelheim Investigational Site, mexico, Mexico

Boehringer Ingelheim Investigational Site, Pretoria, South Africa

Boehringer Ingelheim Investigational Site, Boksburg, South Africa

Boehringer Ingelheim Investigational Site, Lenasia, South Africa

Boehringer Ingelheim Investigational Site, Durban, South Africa

Boehringer Ingelheim Investigational Site, Cape Town, South Africa

Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa

Boehringer Ingelheim Investigational Site, Johannesburg, South Africa

Boehringer Ingelheim Investigational Site, Benoni, South Africa

Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States

Boehringer Ingelheim Investigational Site, Fairhope, Alabama, United States

Boehringer Ingelheim Investigational Site, Tempe, Arizona, United States

Boehringer Ingelheim Investigational Site, Chandler, Arizona, United States

Boehringer Ingelheim Investigational Site, Long Beach, California, United States

Boehringer Ingelheim Investigational Site, Spring Valley, California, United States

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Boehringer Ingelheim Investigational Site, San Diego, California, United States

Boehringer Ingelheim Investigational Site, Sacramento, California, United States

Boehringer Ingelheim Investigational Site, Santa Ana, California, United States

Boehringer Ingelheim Investigational Site, Riverside, California, United States

Boehringer Ingelheim Investigational Site, Encinitas, California, United States

Boehringer Ingelheim Investigational Site, Encino, California, United States

Boehringer Ingelheim Investigational Site, Los Angeles, California, United States

Boehringer Ingelheim Investigational Site, Stratford, Connecticut, United States

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Boehringer Ingelheim Investigational Site, North Dartmouth, Massachusetts, United States

Boehringer Ingelheim Investigational Site, Bay City, Michigan, United States

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Boehringer Ingelheim Investigational Site, Florissant, Missouri, United States

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Boehringer Ingelheim Investigational Site, Cherry Hill, New Jersey, United States

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Boehringer Ingelheim Investigational Site, Williamsville, New York, United States

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Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States

Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States

Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States

Boehringer Ingelheim Investigational Site, Lenior, North Carolina, United States

Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States

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Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States

Boehringer Ingelheim Investigational Site, Marion, Ohio, United States

Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Portland, Oregon, United States

Boehringer Ingelheim Investigational Site, Lansdale, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Penndel, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States

Boehringer Ingelheim Investigational Site, Beaufort, South Carolina, United States

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Boehringer Ingelheim Investigational Site, New Tazewell, Tennessee, United States

Boehringer Ingelheim Investigational Site, Selmer, Tennessee, United States

Boehringer Ingelheim Investigational Site, Cordova, Tennessee, United States

Boehringer Ingelheim Investigational Site, Jackson, Tennessee, United States

Boehringer Ingelheim Investigational Site, Carrollton, Texas, United States

Boehringer Ingelheim Investigational Site, Lake Jackson, Texas, United States

Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

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Ending date: December 2007
Last updated: March 6, 2008