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Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Olmesartan medoxomil (Drug); Amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary outcome:

To evaluate the number (%) of patients achieving BP goal.

To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation

Eligibility

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

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

Locations and Contacts

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Mobile, Alabama, United States

Muscle Shoals, Alabama, United States

Tuscumbia, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Beverly Hills, California, United States

Buena Park, California, United States

Cypress, California, United States

Encino, California, United States

Fountain Valley, California, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Gatos, California, United States

Pico Rivera, California, United States

Rancho Mirage, California, United States

Roseville, California, United States

Sacramento, California, United States

San Francisco, California, United States

Santa Ana, California, United States

Spring Valley, California, United States

Temecula, California, United States

Tustin, California, United States

Walnut Creek, California, United States

Golden, Colorado, United States

Bristol, Connecticut, United States

Stratford, Connecticut, United States

Newark, Delaware, United States

Washington, District of Columbia, United States

Clearwater, Florida, United States

Coral Gables, Florida, United States

Daytona Beach, Florida, United States

Deland, Florida, United States

Ft. Lauderdale, Florida, United States

Hialeah, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Kissimmee, Florida, United States

Merritt Island, Florida, United States

Miami, Florida, United States

New Port Richey, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Palm Harbor, Florida, United States

Pembroke Pines, Florida, United States

Pinellas Park, Florida, United States

Sarasota, Florida, United States

Sebastian, Florida, United States

Stuart, Florida, United States

Tamarac, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Blairsville, Georgia, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Evansville, Indiana, United States

Indianapolis, Indiana, United States

Arkansas City, Kansas, United States

Shawnee, Kansas, United States

Erlanger, Kentucky, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Auburn, Maine, United States

Oxon Hill, Maryland, United States

Benzonia, Michigan, United States

Cadillac, Michigan, United States

Livonia, Michigan, United States

Troy, Michigan, United States

Brooklyn Center, Minnesota, United States

Olive Branch, Mississippi, United States

Kansas City, Missouri, United States

Butte, Montana, United States

Omaha, Nebraska, United States

Henderson, Nevada, United States

Berlin, New Jersey, United States

Elizabeth, New Jersey, United States

Hackensack, New Jersey, United States

South Bound Brook, New Jersey, United States

Turnersville, New Jersey, United States

East Syracuse, New York, United States

Manlius, New York, United States

Rochester, New York, United States

Kinston, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Statesville, North Carolina, United States

Wilmington, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Lyndhurst, Ohio, United States

Marion, Ohio, United States

Mogadore, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Beaver, Pennsylvania, United States

Bensalem, Pennsylvania, United States

Downingtown, Pennsylvania, United States

Feasterville, Pennsylvania, United States

Fleetwood, Pennsylvania, United States

Lansdale, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Uniontown, Pennsylvania, United States

Cranston, Rhode Island, United States

Anderson, South Carolina, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Simpsonville, South Carolina, United States

Bristol, Tennessee, United States

Nashville, Tennessee, United States

New Tazewell, Tennessee, United States

Arlington, Texas, United States

Austin, Texas, United States

Carrollton, Texas, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Lake Jackson, Texas, United States

Midland, Texas, United States

New Braunfels, Texas, United States

San Angelo, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Burke, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Suffolk, Virginia, United States

Lakewood, Washington, United States

Olympia, Washington, United States

Charleston, West Virginia, United States

Madison, Wisconsin, United States

Additional Information

Starting date: May 2005
Last updated: December 12, 2007

Page last updated: August 20, 2015

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