HypertensionPhase 3NCT00185133
Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension
A Phase 3 study testing Olmesartan medoxomil and Amlodipine in people with Hypertension, run by Daiichi Sankyo at 139 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Olmesartan medoxomil and Amlodipine
- How many people
- 1,900 participants
- Where
- 139 sitesUnited States
- Study dates
- May 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
139 sites in 1 country.
139 sites in 1 country
United States139 sites
Study site
Anaheim, California
Study site
Anderson, South Carolina
Study site
Arkansas City, Kansas
Study site
Arlington, Texas
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Atlanta, Georgia
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Auburn, Maine
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Austin, Texas
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Beaver, Pennsylvania
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Bensalem, Pennsylvania
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Benzonia, Michigan
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Berlin, New Jersey
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Beverly Hills, California
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Birmingham, Alabama
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Blairsville, Georgia
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Boise, Idaho
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Bristol, Connecticut
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Bristol, Tennessee
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Brooklyn Center, Minnesota
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Buena Park, California
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Burke, Virginia
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Butte, Montana
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Cadillac, Michigan
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Carrollton, Texas
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Charleston, South Carolina
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Charleston, West Virginia
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Columbus, Ohio
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Coral Gables, Florida
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Corpus Christi, Texas
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Cranston, Rhode Island
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Cypress, California
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Dallas, Texas
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Daytona Beach, Florida
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DeLand, Florida
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Downingtown, Pennsylvania
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East Syracuse, New York
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Elizabeth, New Jersey
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Encino, California
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Erlanger, Kentucky
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Eugene, Oregon
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Evansville, Indiana
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Feasterville, Pennsylvania
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Fleetwood, Pennsylvania
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Fort Lauderdale, Florida
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Fort Worth, Texas
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Fountain Valley, California
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Golden, Colorado
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Greer, South Carolina
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Hackensack, New Jersey
Study site
Henderson, Nevada
Study site
Hialeah, Florida
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Hollywood, Florida
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Houston, Texas
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Huntsville, Alabama
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Indianapolis, Indiana
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Jacksonville, Florida
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Kansas City, Missouri
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Kinston, North Carolina
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Kissimmee, Florida
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La Jolla, California
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Lake Jackson, Texas
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Lakewood, Washington
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Lansdale, Pennsylvania
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Little Rock, Arkansas
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Livonia, Michigan
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Long Beach, California
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Los Angeles, California
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Los Gatos, California
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Lyndhurst, Ohio
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Madison, Wisconsin
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Manlius, New York
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Marion, Ohio
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Merritt Island, Florida
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Miami, Florida
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Midland, Texas
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Mobile, Alabama
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Mogadore, Ohio
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Mt. Pleasant, South Carolina
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Muscle Shoals, Alabama
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Nashville, Tennessee
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New Braunfels, Texas
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New Orleans, Louisiana
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New Port Richey, Florida
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New Tazewell, Tennessee
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Newark, Delaware
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Norfolk, Virginia
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olive Branch, Mississippi
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Olympia, Washington
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Omaha, Nebraska
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Orlando, Florida
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Oxon Hill, Maryland
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Palm Harbor, Florida
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Pembroke Pines, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pico Rivera, California
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Pinellas Park, Florida
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Portland, Oregon
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Raleigh, North Carolina
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Rancho Mirage, California
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Richmond, Virginia
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Rochester, New York
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Roseville, California
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Sacramento, California
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Salisbury, North Carolina
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Salt Lake City, Utah
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San Angelo, Texas
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San Antonio, Texas
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San Francisco, California
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Santa Ana, California
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Sarasota, Florida
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Sebastian, Florida
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Shawnee Mission, Kansas
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Shreveport, Louisiana
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Simpsonville, South Carolina
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South Bound Brook, New Jersey
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Spring Valley, California
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Statesville, North Carolina
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Stratford, Connecticut
Study site
Stuart, Florida
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Suffolk, Virginia
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Tamarac, Florida
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Temecula, California
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Troy, Michigan
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Tucson, Arizona
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Tulsa, Oklahoma
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Turnersville, New Jersey
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Tuscumbia, Alabama
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Tustin, California
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Uniontown, Pennsylvania
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Walnut Creek, California
Study site
Washington D.C., District of Columbia
Study site
West Palm Beach, Florida
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
About this study
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
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
- Conditions
- Hypertension
- Being tested
- Olmesartan medoxomil, Amlodipine
- Keywords
- Treatment of high blood pressure in mild to severe hypertensive patients
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
AmlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,900 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185133
- Sponsor's protocol ID
- CS8663-A-U301
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00185133
- Acronym / sponsor ID
- CS8663-A-U301
- Conditions
- Hypertension
- Keywords
- Treatment of high blood pressure in mild to severe hypertensive patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jan 2007
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olmesartan medoxomil | Drug | – |
| Amlodipine | Drug | – |
Primary outcome
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm
2 secondary outcomes
To evaluate the number (%) of patients achieving BP goal.
To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
139 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olmesartan medoxomil and Amlodipine in people with Hypertension, run by Daiichi Sankyo at 139 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 139 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.