A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
NCT ID: NCT00791258
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
999 participants
INTERVENTIONAL
2008-11-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks
amlodipine and olmesartan medoxomil tablets
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
hydrochlorothiazide tablets
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
Interventions
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amlodipine and olmesartan medoxomil tablets
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
hydrochlorothiazide tablets
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypertension uncontrolled on current monotherapy
* Females:
* negative serum pregnancy test at screening
* post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control
Exclusion Criteria
* Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
* Diabetes requiring insulin
* Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
* History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
* History of Class III or IV congestive heart failure
* History of stroke or transient ischemic attack within the last 1 year
18 Years
ALL
No
Sponsors
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Integrium
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Green Valley, Arizona, United States
Mesa, Arizona, United States
Sierra Vista, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Harbor City, California, United States
National City, California, United States
Tustin, California, United States
Westlake Village, California, United States
Colorado Springs, Colorado, United States
Pueblo, Colorado, United States
Milford, Connecticut, United States
Boynton Beach, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Deerfield Beach, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Kissimmee, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Boise, Idaho, United States
Addison, Illinois, United States
Orland Park, Illinois, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Columbia, Maryland, United States
Elkridge, Maryland, United States
Oxon Hill, Maryland, United States
Reisterstown, Maryland, United States
Stevensville, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Edison, New Jersey, United States
Sewell, New Jersey, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Harrisburg, North Carolina, United States
Hickory, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Havertown, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Mt. Pleasant, South Carolina, United States
New Tazewell, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Longview, Texas, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Walla Walla, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.
Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.
Other Identifiers
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CS8663-404
Identifier Type: -
Identifier Source: org_study_id
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