To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension

Completed · Phase 1

Conditions studied: Osteoarthritis, Hypertension

In brief

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

Key facts

Study ID

NCT00662896

Run by

NicOx

People needed

300

Starts

2008-03-01

Expected to finish

2008-12-01

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 Blockers (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 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.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Long Beach, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Upland, California, United States
• Study site — Denver, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Milford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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