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

April 16, 2008
June 16, 2011
March 2008
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00662896 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
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.

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Hypertension
  • Drug: naproxcinod 375 mg bid
    naproxcinod 375 mg bid
  • Drug: naproxcinod 750 mg bid
    naproxcinod 750 mg bid
  • Drug: naproxen 250 mg bid
    naproxen 250 mg bid
  • Drug: naproxen 500 mg bid
    naproxen 500 mg bid
  • Drug: ibuprofen 600 mg tid
    ibuprofen 600 mg tid
  • Experimental: naproxcinod 375 mg bid
    Intervention: Drug: naproxcinod 375 mg bid
  • Active Comparator: naproxen 250 mg bid
    Intervention: Drug: naproxen 250 mg bid
  • Active Comparator: ibuprofen 600 mg tid
    Intervention: Drug: ibuprofen 600 mg tid
  • Experimental: naproxcinod 750 mg bid
    Intervention: Drug: naproxcinod 750 mg bid
  • Active Comparator: naproxen 500 mg bid
    Intervention: Drug: naproxen 500 mg bid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662896
HCT 3012-X-112
Yes
NicOx, NicOx.
NicOx
Not Provided
Not Provided
NicOx
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP