To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in
patients with osteoarthritis and controlled essential hypertension
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Men/Women, 40 or older, diagnosed with hip or knee osteoarthritis.
- 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
Blockers (ARB) or Beta-Blocker (BB).
- Must be current chronic user of NSAIDS or acetaminophen.
- Must discontinue all analgesic therapy at Screening.
Exclusion Criteria:
- More than two different classes of antihypertensive drugs.
- 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 history of a medical disease that could interfere with the study
objectives or put the patient's safety at risk.
- Current or expected use of anticoagulants.
- Participation within 30 days prior to pre-screening in another investigational study.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Sierra Vista, Arizona, United States
Carmichael, California, United States
Fair Oaks, California, United States
Long Beach, California, United States
Pico Rivera, California, United States
Upland, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Milford, Connecticut, United States
Washington, District of Columbia, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jupiter, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Arlington Heights, Illinois, United States
Peoria, Illinois, United States
Elizabethtown, Kentucky, United States
Erlanger, Kentucky, United States
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Florissant, Missouri, United States
Missoula, Montana, United States
Grand Island, Nebraska, United States
Henderson, Nevada, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Hickory, North Carolina, United States
Lenoir, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Havertown, Pennsylvania, United States
Tipton, Pennsylvania, United States
Charleston, South Carolina, United States
Kingsport, Tennessee, United States
New Tazewell, Tennessee, United States
Dallas, Texas, United States
Irving, Texas, United States
Longview, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States