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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)

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ClinicalTrials.gov Identifier: NCT00662610
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : June 17, 2011
Information provided by:

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

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Primary Completion Date : August 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662610

  Hide Study 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
More Information

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00662610     History of Changes
Other Study ID Numbers: HCT3012-X-111
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors