To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
HCT3012-X-112
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.
1 other identifier
interventional
300
1 country
57
Brief Summary
To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2008
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 17, 2011
June 1, 2011
6 months
April 16, 2008
June 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
15 weeks
Secondary Outcomes (2)
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.
15 weeks
To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.
15 weeks
Study Arms (5)
naproxcinod 375 mg bid
EXPERIMENTALnaproxen 250 mg bid
ACTIVE COMPARATORibuprofen 600 mg tid
ACTIVE COMPARATORnaproxcinod 750 mg bid
EXPERIMENTALnaproxen 500 mg bid
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Study Sites (57)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Sierra Vista, Arizona, United States
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Carmichael, California, United States
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Fair Oaks, California, United States
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Long Beach, California, United States
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Pico Rivera, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Milford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Ormond Beach, Florida, United States
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Pembroke Pines, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Arlington Heights, Illinois, United States
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Peoria, Illinois, United States
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Elizabethtown, Kentucky, United States
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Erlanger, Kentucky, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Towson, Maryland, United States
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Florissant, Missouri, United States
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Missoula, Montana, United States
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Grand Island, Nebraska, United States
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Henderson, Nevada, United States
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Albuquerque, New Mexico, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Hickory, North Carolina, United States
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Lenoir, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Havertown, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Charleston, South Carolina, United States
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Kingsport, Tennessee, United States
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New Tazewell, Tennessee, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Madison, Wisconsin, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 21, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2008
Study Completion
December 1, 2008
Last Updated
June 17, 2011
Record last verified: 2011-06