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

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00662896
First received: April 16, 2008
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen. [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00662896

  Show 57 Study Locations
Sponsors and Collaborators
NicOx
  More Information

Additional Information:
No publications provided

Responsible Party: NicOx, NicOx.
ClinicalTrials.gov Identifier: NCT00662896     History of Changes
Other Study ID Numbers: HCT 3012-X-112
Study First Received: April 16, 2008
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014