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)

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 16, 2008
Last updated: June 16, 2011
Last verified: June 2011
To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

Condition Intervention Phase
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:

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.

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00662610

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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
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Terre Haute, Indiana, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Edison, New Jersey, United States
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Binghamton, New York, United States
Johnson City, New York, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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Clarksville, Tennessee, United States
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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 
Study First Received: April 16, 2008
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 27, 2016