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

Phase 1

Completed

• Conditions: Osteoarthritis; Hypertension
• Interventions: Drug: naproxcinod 375 mg -750 mg -1125 mg bid; Drug: naproxen 250 mg - 500mg -750 mg bid

• Registration Number: NCT00662610
• Lead Sponsor: NicOx

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-21
• Primary Completion: 2008-08
• Study Completion: 2008-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
naproxcinod 375 mg - 750 mg -1125 mg bid	naproxcinod 375 mg -750 mg -1125 mg bid	dose escalating
naproxen 250 mg -500 mg -750 mg bid	naproxen 250 mg - 500mg -750 mg bid	dose escalating

Primary Outcome Measures

Name	Time	Method
To characterize the 24-hour arterial blood pressure profile of different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.	11 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.	11 weeks