Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
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
1 other identifier
interventional
1,900
1 country
139
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started May 2005
Typical duration for phase_3 hypertension
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedDecember 24, 2018
December 1, 2007
September 9, 2005
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
Secondary Outcomes (2)
To evaluate the number (%) of patients achieving BP goal.
To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (139)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Muscle Shoals, Alabama, United States
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Tuscumbia, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Buena Park, California, United States
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Cypress, California, United States
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Encino, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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Pico Rivera, California, United States
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Rancho Mirage, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Temecula, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Golden, Colorado, United States
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Bristol, Connecticut, United States
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Stratford, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Daytona Beach, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Pinellas Park, Florida, United States
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Sarasota, Florida, United States
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Sebastian, Florida, United States
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Stuart, Florida, United States
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Tamarac, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Blairsville, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Arkansas City, Kansas, United States
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Shawnee Mission, Kansas, United States
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Erlanger, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Auburn, Maine, United States
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Oxon Hill, Maryland, United States
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Benzonia, Michigan, United States
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Cadillac, Michigan, United States
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Livonia, Michigan, United States
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Troy, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Berlin, New Jersey, United States
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Elizabeth, New Jersey, United States
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Hackensack, New Jersey, United States
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South Bound Brook, New Jersey, United States
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Turnersville, New Jersey, United States
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East Syracuse, New York, United States
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Manlius, New York, United States
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Rochester, New York, United States
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Kinston, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Mogadore, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Fleetwood, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Midland, Texas, United States
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New Braunfels, Texas, United States
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San Angelo, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Lakewood, Washington, United States
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Olympia, Washington, United States
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Charleston, West Virginia, United States
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Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
May 1, 2005
Study Completion
January 1, 2007
Last Updated
December 24, 2018
Record last verified: 2007-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/