An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
NCT ID: NCT00185068
Last Updated: 2005-09-16
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
110 participants
INTERVENTIONAL
2004-03-31
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Olmesartan medoxomil
Olmesartan medoxomil/hydrochlorothiazide
Hydrochlorothiazide
Eligibility Criteria
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Inclusion Criteria
* 2\. Patients with stage II systolic hypertension
* 3\. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.
Exclusion Criteria
2\. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
3\. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP \> 200 mm Hg).
4\. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
5\. Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
7\. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.
8\. Laboratory test values considered clinically significant by the investigator.
9\. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin \> 3 times the upper limit of normal.
10\. Pregnant or lactating females.
* 11\. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Locations
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Fort Lauderdale, California, United States
Long Beach, California, United States
Roseville, California, United States
Sacramento, California, United States
Santa Anna, California, United States
Tustin, California, United States
Westlake Village, California, United States
DeLand, Florida, United States
Pembroke Pines, Florida, United States
Orland Park, Illinois, United States
New Orleans, Louisiana, United States
Auburn, Maine, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
Oklahoma City, Oklahoma, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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866-443
Identifier Type: -
Identifier Source: org_study_id