To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension (HCT3012-X-112)

NicOx

Status and phase: Completed; Phase 1

Conditions: Hypertension; Osteoarthritis

Treatments: Drug: naproxen 250 mg bid; Drug: naproxcinod 375 mg bid; Drug: naproxcinod 750 mg bid; Drug: naproxen 500 mg bid; Drug: ibuprofen 600 mg tid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662896

HCT 3012-X-112

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 5 patient groups

naproxcinod 375 mg bid

Experimental group

Treatment:

Drug: naproxcinod 375 mg bid

naproxen 250 mg bid

Active Comparator group

Treatment:

Drug: naproxen 250 mg bid

ibuprofen 600 mg tid

Active Comparator group

Treatment:

Drug: ibuprofen 600 mg tid

naproxcinod 750 mg bid

Experimental group

Treatment:

Drug: naproxcinod 750 mg bid

naproxen 500 mg bid

Active Comparator group

Treatment:

Drug: naproxen 500 mg bid