A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
NCT ID: NCT00662610
Last Updated: 2011-06-17
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
PHASE1
120 participants
INTERVENTIONAL
2008-03-31
2008-11-30
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
DOUBLE
Study Groups
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naproxcinod 375 mg - 750 mg -1125 mg bid
dose escalating
naproxcinod 375 mg -750 mg -1125 mg bid
naproxcinod 375 mg -750 mg -1125 mg bid
naproxen 250 mg -500 mg -750 mg bid
dose escalating
naproxen 250 mg - 500mg -750 mg bid
naproxen 250 mg - 500mg -750 mg bid
Interventions
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naproxcinod 375 mg -750 mg -1125 mg bid
naproxcinod 375 mg -750 mg -1125 mg bid
naproxen 250 mg - 500mg -750 mg bid
naproxen 250 mg - 500mg -750 mg bid
Eligibility Criteria
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Inclusion Criteria
* Hypertensive patient with treated and controlled essential hypertension.
* Must receive at least one antihypertensive treatment from the following drug classes: Diuretic, Angiotensin-Converting Enzyme (ACE) inhibitor, Angiotensin Receptor Blocker (ARB) or Beta-Blocker (BB).
* Must be current chronic user of NSAIDS or acetaminophen.
* Must discontinue all analgesic therapy at Screening.
Exclusion Criteria
* Uncontrolled diabetes.
* Hepatic or renal impairment.
* A history of alcohol/drug abuse.
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding.
* History of congestive heart failure.
* Clinically relevant abnormal ECG.
* Current or expected use of anticoagulants.
* Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
* Participation within 30 days prior to pre-screening in another investigational study.
40 Years
ALL
No
Sponsors
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NicOx
INDUSTRY
Responsible Party
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NicOx.
Locations
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Mobile, Alabama, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Buena Park, California, United States
Colorado Springs, Colorado, United States
Boynton Beach, Florida, United States
Stockbridge, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Newburgh, Indiana, United States
Terre Haute, Indiana, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Edison, New Jersey, United States
Binghamton, New York, United States
Johnson City, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Clarksville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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HCT3012-X-111
Identifier Type: -
Identifier Source: org_study_id
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