To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension - Tabular View

Tracking Information
First Received Date ^ICMJE	April 16, 2008
Last Updated Date	January 27, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 16, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00662896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 16, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
Official Title ^ICMJE	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.
Brief Summary	To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
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 Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Osteoarthritis Hypertension
Intervention ^ICMJE	Drug: naproxcinod, naproxen, ibuprofen
Study Arms / Comparison Groups	Active Comparator: 375mg, 750mg bid Active Comparator: 250mg, 500mg bid Active Comparator: 600mg tid
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	300
Completion Date	December 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00662896
Responsible Party	NicOx, NicOx.
Study ID Numbers ^ICMJE	HCT 3012-X-112
Study Sponsor ^ICMJE	NicOx
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NicOx
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP