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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NicOx
• Treatments: Naproxen; Naproxen-n-butyl nitrate

Criteria

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 Blocker (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 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.