Clinical trial NCT00662896: To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Hypertension
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 15 weeks
Secondary outcomes:
measure: 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.
timeFrame: 15 weeks
measure: To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Sierra Vista
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Fair Oaks
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: Upland
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Elizabethtown
country: United States
state: Kentucky
city: Erlanger
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Florissant
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Grand Island
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Lenoir
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Havertown
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
References: