Clareo Health | A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NicOx
This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 1:1 ratio.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
