A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure

Condition(s) targeted: Osteoarthritis; Hypertension

Intervention: naproxcinod, naproxen (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: NicOx

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: 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.

Secondary outcome: 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.

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.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Mobile, Alabama, United States; Recruiting
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Tucson, Arizona, United States; Recruiting
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Tempe, Arizona, United States; Recruiting
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Buena Park, California, United States; Recruiting
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Beverly Hills, California, United States; Recruiting
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Colorado Springs, Colorado, United States; Recruiting
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Winston-Salem, North Carolina, United States; Recruiting
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Cleveland, Ohio, United States; Recruiting
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Duncansville, Pennsylvania, United States; Recruiting
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Philadelphia, Pennsylvania, United States; Recruiting
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Clarksville, Tennessee, United States; Recruiting
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Austin, Texas, United States; Recruiting
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Dallas, Texas, United States; Recruiting
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Houston, Texas, United States; Recruiting
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Houston, Texas, United States; Recruiting
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NicOx website

Starting date: March 2008
Last updated: April 16, 2008