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To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension (HCT3012-X-112)

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ClinicalTrials.gov Identifier: NCT00662896
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
NicOx

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Hypertension Drug: naproxcinod 375 mg bid Drug: naproxcinod 750 mg bid Drug: naproxen 250 mg bid Drug: naproxen 500 mg bid Drug: ibuprofen 600 mg tid Phase 1

Detailed Description:
This is a 16-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod, naproxen, and ibuprofen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to naproxcinod 375mg, naproxcinod 750mg, naproxen 250mg, naproxen 500mg, or ibuprofen 600mg in a 1:1:1:1:1 ratio.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: naproxcinod 375 mg bid Drug: naproxcinod 375 mg bid
naproxcinod 375 mg bid
Active Comparator: naproxen 250 mg bid Drug: naproxen 250 mg bid
naproxen 250 mg bid
Active Comparator: ibuprofen 600 mg tid Drug: ibuprofen 600 mg tid
ibuprofen 600 mg tid
Experimental: naproxcinod 750 mg bid Drug: naproxcinod 750 mg bid
naproxcinod 750 mg bid
Active Comparator: naproxen 500 mg bid Drug: naproxen 500 mg bid
naproxen 500 mg bid


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 15 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 15 weeks ]
  2. To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen. [ Time Frame: 15 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Blockers (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 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.
Contacts and Locations
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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): NCT00662896


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Sponsors and Collaborators
NicOx
More Information
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Additional Information:
Nicox web-site  This link exits the ClinicalTrials.gov site

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00662896     History of Changes
Other Study ID Numbers: HCT 3012-X-112
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011

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