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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662610

Acronym

HCT3012-X-111

Enrollment

120

Registered

2008-04-21

Start date

2008-03-31

Completion date

2008-11-30

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 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.

Interventions

DRUGnaproxcinod 375 mg -750 mg -1125 mg bid

naproxcinod 375 mg -750 mg -1125 mg bid

DRUGnaproxen 250 mg - 500mg -750 mg bid

naproxen 250 mg - 500mg -750 mg bid

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 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026