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To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension

Information source: NicOx
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis; Hypertension

Intervention: naproxcinod 375 mg bid (Drug); naproxcinod 750 mg bid (Drug); naproxen 250 mg bid (Drug); naproxen 500 mg bid (Drug); ibuprofen 600 mg tid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: NicOx

Summary

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

Clinical Details

Official title: A 16-week, Phase 1, Multicenter, Double-Blind, Randomized, Naproxen and Ibuprofen-controlled, Parallel-Group Pharmacological Study, to Assess the Effect of Naproxcinod (375mg and750mg, Bid) Compared to Doses of Naproxen (250mg and 500mg, Bid) and to Ibuprofen (600mg, Tid) on Arterial Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Osteoarthritis Patients With Controlled Essential Hypertension.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To characterize the 24-hour arterial blood pressure profile of naproxcinod, compared to naproxen as measured by ABPM, through assessing the mean change from baseline in patients with OA and controlled essential hypertension.

Secondary outcome:

To characterize the 24-hour arterial blood pressure profile of naproxcinod compared to ibuprofen as measured by ABPM, through assessing the mean change from baseline in patients with osteoarthritis and controlled essential hypertension.

To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.

Detailed 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.

Eligibility

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 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.

Locations and Contacts

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Sierra Vista, Arizona, United States

Carmichael, California, United States

Fair Oaks, California, United States

Long Beach, California, United States

Pico Rivera, California, United States

Upland, California, United States

Denver, Colorado, United States

Farmington, Connecticut, United States

Milford, Connecticut, United States

Washington, District of Columbia, United States

Clearwater, Florida, United States

DeLand, Florida, United States

Fort Myers, Florida, United States

Gainesville, Florida, United States

Jupiter, Florida, United States

Kissimmee, Florida, United States

Miami, Florida, United States

Ormond Beach, Florida, United States

Pembroke Pines, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Marietta, Georgia, United States

Arlington Heights, Illinois, United States

Peoria, Illinois, United States

Elizabethtown, Kentucky, United States

Erlanger, Kentucky, United States

Metairie, Louisiana, United States

Shreveport, Louisiana, United States

Auburn, Maine, United States

Baltimore, Maryland, United States

Towson, Maryland, United States

Florissant, Missouri, United States

Missoula, Montana, United States

Grand Island, Nebraska, United States

Henderson, Nevada, United States

Albuquerque, New Mexico, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Concord, North Carolina, United States

Hickory, North Carolina, United States

Lenoir, North Carolina, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Havertown, Pennsylvania, United States

Tipton, Pennsylvania, United States

Charleston, South Carolina, United States

Kingsport, Tennessee, United States

New Tazewell, Tennessee, United States

Dallas, Texas, United States

Irving, Texas, United States

Longview, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Madison, Wisconsin, United States

Additional Information

Nicox web-site

Starting date: March 2008
Last updated: June 16, 2011

Page last updated: August 23, 2015

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