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
- OsteoarthritisHypertension
- Interventions
- 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.
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of action of naproxcinod in modulating COX-2 and EP4 receptors for blood pressure control in osteoarthritis patients with hypertension?
How does naproxcinod compare to naproxen in managing 24-hour ambulatory blood pressure profiles in patients with controlled essential hypertension and osteoarthritis?
Are there specific biomarkers that correlate with differential blood pressure responses to naproxcinod versus naproxen in osteoarthritis patients with hypertension?
What are the potential adverse events associated with naproxcinod's dual COX-2 and EP4 inhibition in phase 1 trials for osteoarthritis and hypertension management?
How do EP4 receptor antagonists like naproxcinod influence cardiovascular outcomes compared to traditional NSAIDs in patients with comorbid osteoarthritis and hypertension?