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

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”

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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: naproxcinod 375 mg - 750 mg -1125 mg bid
  • dose escalating
• Active Comparator: naproxen 250 mg -500 mg -750 mg bid
  • dose escalating

Primary Measures

• 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.
  • Time Frame: 11 weeks
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 11 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: NicOx Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662610

Study ID Number: HCT3012-X-111

ClinicalTrials.gov Identifier: NCT00662610

Health Authority: United States: Food and Drug Administration