Clinical trial NCT00662610: A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
Official title: A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen 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: 120
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 on arterial blood pressure patients with osteoarthritis and controlled essential hypertension

Detailed description: This is a 12-week, randomized, double-blind, multicenter study comparing the effect of naproxcinod and naproxen on 24 hour arterial blood pressure profile. Patients will be randomly allocated to different naproxcinod or naproxen doses in a 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 Blocker (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 expected use of anticoagulants.
* Current or history of any medical disease that could interfere with the study objectives or put the patient's safety at risk.
* 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 different doses of naproxcinod, as measured by ABPM after each treatment period, compared to different doses of naproxen after three 3-week forced titration.
timeFrame: 11 weeks
Secondary outcomes:
measure: To evaluate the general safety and tolerability as well as the PK/PD profile of different doses of naproxcinod compared to different doses of naproxen.
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Terre Haute
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Billings
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Edison
country: United States
state: New Jersey
city: Binghamton
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Clarksville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
References: