Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2002-11-30
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
2
Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure
atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Interventions
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olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure
Tablets and capsules for oral administration once or twice daily for up to 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 18-75 years of age
* Mean seated diastolic BP 90-109 or mean seated systolic BP of 140-179
Exclusion Criteria
* Renal disease
* Diabetes mellitus
* Serum creatinine \>3.0 mg/dL
* Hemoglobin \<10 mg/dL (males) or \<9mg/dL (females)
* WBC count \<2000 cells/mL
* Platelet count \<100,000 cells/mL
* Either ALT \& AST \>2.5 x upper limit of normal
* BMI \>35 kg/m2
* TIA or cerebrovascular attack within 3 months of study entry
18 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Daiichi Sankyo, Inc.
Locations
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Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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866-432
Identifier Type: -
Identifier Source: org_study_id