Overview

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.