Status:
COMPLETED
To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
Lead Sponsor:
NicOx
Conditions:
Osteoarthritis
Hypertension
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
Detailed Description
This is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. Patients will be randomly alloca...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00662896
Start Date
March 1 2008
End Date
December 1 2008
Last Update
June 17 2011
Active Locations (57)
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1
Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Sierra Vista, Arizona, United States
4
Carmichael, California, United States