NCT00662610

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

A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen 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: 120 (estimated)
• Sponsor: NicOx · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Hypertension

Interventions

Type	Name	Description
DRUG	naproxcinod 375 mg -750 mg -1125 mg bid	naproxcinod 375 mg -750 mg -1125 mg bid
DRUG	naproxen 250 mg - 500mg -750 mg bid	naproxen 250 mg - 500mg -750 mg bid

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-11-01
• First posted: 2008-04-21
• Last updated: 2011-06-17

Locations

29 sites across 1 country: United States