Clinical trial NCT00185133: Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
Official title: A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Treatment of high blood pressure in mild to severe hypertensive patients
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age


Eligibility criteria: Inclusion Criteria:

* Male or female patients
* 18 years of age or older (20% equal to or older than 65 years)
* With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

* Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

Primary outcomes:
measure: Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
Secondary outcomes:
measure: To evaluate the number (%) of patients achieving BP goal.
measure: To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Muscle Shoals
country: United States
state: Alabama
city: Tuscumbia
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Cypress
country: United States
state: California
city: Encino
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Temecula
country: United States
state: California
city: Tustin
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Stratford
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: DeLand
country: United States
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city: Fort Lauderdale
country: United States
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city: Hialeah
country: United States
state: Florida
city: Hollywood
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city: Jacksonville
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city: Kissimmee
country: United States
state: Florida
city: Merritt Island
country: United States
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city: Miami
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city: New Port Richey
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city: Orlando
country: United States
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city: Palm Harbor
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city: Pembroke Pines
country: United States
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state: Florida
city: Sebastian
country: United States
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city: Stuart
country: United States
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city: Tamarac
country: United States
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city: West Palm Beach
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state: Florida
city: Atlanta
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state: Georgia
city: Blairsville
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state: Idaho
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city: Shawnee Mission
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city: Erlanger
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city: Shreveport
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state: Maine
city: Oxon Hill
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state: Maryland
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city: Cadillac
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city: Brooklyn Center
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city: Olive Branch
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city: Kansas City
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city: Omaha
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state: Nebraska
city: Henderson
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state: Nevada
city: Berlin
country: United States
state: New Jersey
city: Elizabeth
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city: Hackensack
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city: South Bound Brook
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city: Turnersville
country: United States
state: New Jersey
city: East Syracuse
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state: New York
city: Manlius
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city: Rochester
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city: Kinston
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Statesville
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state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Beaver
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Downingtown
country: United States
state: Pennsylvania
city: Feasterville
country: United States
state: Pennsylvania
city: Fleetwood
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: New Braunfels
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Suffolk
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Olympia
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
References: