A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure (HCT3012-X-111)

NicOx

Status and phase: Completed; Phase 1

Conditions: Hypertension; Osteoarthritis

Treatments: Drug: naproxen 250 mg - 500mg -750 mg bid; Drug: naproxcinod 375 mg -750 mg -1125 mg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662610

HCT3012-X-111

Details and patient eligibility

About

To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

naproxcinod 375 mg - 750 mg -1125 mg bid

Experimental group

Description:

dose escalating

Treatment:

Drug: naproxcinod 375 mg -750 mg -1125 mg bid

naproxen 250 mg -500 mg -750 mg bid

Active Comparator group

Description:

dose escalating

Treatment:

Drug: naproxen 250 mg - 500mg -750 mg bid