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

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Hypertension	Drug: naproxcinod 375 mg -750 mg -1125 mg bid Drug: naproxen 250 mg - 500mg -750 mg bid	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by NicOx:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Study Completion Date:	November 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: naproxcinod 375 mg - 750 mg -1125 mg bid dose escalating	Drug: naproxcinod 375 mg -750 mg -1125 mg bid naproxcinod 375 mg -750 mg -1125 mg bid
Active Comparator: naproxen 250 mg -500 mg -750 mg bid dose escalating	Drug: naproxen 250 mg - 500mg -750 mg bid naproxen 250 mg - 500mg -750 mg bid

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662610

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Locations

United States, Alabama

Mobile, Alabama, United States
United States, Arizona

Tempe, Arizona, United States

Tucson, Arizona, United States
United States, California

Beverly Hills, California, United States

Buena Park, California, United States
United States, Colorado

Colorado Springs, Colorado, United States
United States, Florida

Boynton Beach, Florida, United States
United States, Georgia

Stockbridge, Georgia, United States
United States, Idaho

Boise, Idaho, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Evansville, Indiana, United States

Newburgh, Indiana, United States

Terre Haute, Indiana, United States
United States, Kentucky

Louisville, Kentucky, United States
United States, Louisiana

New Orleans, Louisiana, United States
United States, Montana

Billings, Montana, United States
United States, Nevada

Las Vegas, Nevada, United States
United States, New Jersey

Edison, New Jersey, United States
United States, New York

Binghamton, New York, United States

Johnson City, New York, United States
United States, North Carolina

Winston-Salem, North Carolina, United States
United States, Ohio

Cleveland, Ohio, United States
United States, Pennsylvania

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States
United States, Tennessee

Clarksville, Tennessee, United States
United States, Texas

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States
United States, Virginia

Norfolk, Virginia, United States

Sponsors and Collaborators

NicOx

More Information

No publications provided

Responsible Party:	NicOx, NicOx.
ClinicalTrials.gov Identifier:	NCT00662610 History of Changes
Other Study ID Numbers:	HCT3012-X-111
Study First Received:	April 16, 2008
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Osteoarthritis
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Nitric Oxide Donors
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013

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)