A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure

Completed · Phase 1

Conditions studied: Osteoarthritis, Hypertension

In brief

To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

Key facts

Study ID

NCT00662610

Run by

NicOx

People needed

120

Starts

2008-03-01

Expected to finish

2008-11-01

Last updated by the study team

2011-06-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Blocker (ARB) or Beta-Blocker (BB).
• Must be current chronic user of NSAIDS or acetaminophen.
• Must discontinue all analgesic therapy at Screening.

You may not qualify if…

• 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 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Buena Park, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Newburgh, Indiana, United States
• Study site — Terre Haute, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Billings, Montana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Edison, New Jersey, United States
• Study site — Binghamton, New York, United States
• Study site — Johnson City, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Clarksville, Tennessee, United States

Full record on ClinicalTrials.gov

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