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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662896

Acronym

HCT3012-X-112

Enrollment

300

Registered

2008-04-21

Start date

2008-03-31

Completion date

2008-12-31

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Osteoarthritis

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

Interventions

DRUGnaproxcinod 375 mg bid

naproxcinod 375 mg bid

DRUGnaproxcinod 750 mg bid

naproxcinod 750 mg bid

DRUGnaproxen 250 mg bid

naproxen 250 mg bid

DRUGnaproxen 500 mg bid

naproxen 500 mg bid

DRUGibuprofen 600 mg tid

ibuprofen 600 mg tid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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 Blockers (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 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.

Design outcomes

Primary

Measure	Time frame
To characterize the 24-hour arterial blood pressure profile of naproxcinod, compared to naproxen as measured by ABPM, through assessing the mean change from baseline in patients with OA and controlled essential hypertension.	15 weeks

Secondary

Measure	Time frame
To characterize the 24-hour arterial blood pressure profile of naproxcinod compared to ibuprofen as measured by ABPM, through assessing the mean change from baseline in patients with osteoarthritis and controlled essential hypertension.	15 weeks
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.	15 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026