To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
NCT ID: NCT00662896
Last Updated: 2011-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
300 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
NCT00662610
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
NCT04139824
Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male
NCT01404598
Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)
NCT00959439
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
NCT00692055
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
naproxcinod 375 mg bid
naproxcinod 375 mg bid
naproxcinod 375 mg bid
naproxen 250 mg bid
naproxen 250 mg bid
naproxen 250 mg bid
ibuprofen 600 mg tid
ibuprofen 600 mg tid
ibuprofen 600 mg tid
naproxcinod 750 mg bid
naproxcinod 750 mg bid
naproxcinod 750 mg bid
naproxen 500 mg bid
naproxen 500 mg bid
naproxen 500 mg bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
naproxcinod 375 mg bid
naproxcinod 375 mg bid
naproxcinod 750 mg bid
naproxcinod 750 mg bid
naproxen 250 mg bid
naproxen 250 mg bid
naproxen 500 mg bid
naproxen 500 mg bid
ibuprofen 600 mg tid
ibuprofen 600 mg tid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NicOx
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
NicOx.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 D.C., 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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Nicox web-site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCT 3012-X-112
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.