NCT00662896

To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension

A 16-week, Phase 1, Multicenter, Double-Blind, Randomized, Naproxen and Ibuprofen-controlled, Parallel-Group Pharmacological Study, to Assess the Effect of Naproxcinod (375mg and750mg, Bid) Compared to Doses of Naproxen (250mg and 500mg, Bid) and to Ibuprofen (600mg, Tid) on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: NicOx · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.

Conditions

• Osteoarthritis
• Hypertension

Interventions

Type	Name	Description
DRUG	naproxcinod 375 mg bid	naproxcinod 375 mg bid
DRUG	naproxcinod 750 mg bid	naproxcinod 750 mg bid
DRUG	naproxen 250 mg bid	naproxen 250 mg bid
DRUG	naproxen 500 mg bid	naproxen 500 mg bid
DRUG	ibuprofen 600 mg tid	ibuprofen 600 mg tid

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2008-04-21
• Last updated: 2011-06-17

Locations

57 sites across 1 country: United States