A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
HCT3012-X-111
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
1 other identifier
interventional
120
1 country
29
Brief Summary
To assess the effect of naproxcinod vs. naproxen on arterial blood pressure patients with osteoarthritis and controlled essential hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2008
Shorter than P25 for phase_1
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 16, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJune 17, 2011
June 1, 2011
5 months
April 16, 2008
June 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
11 weeks
Secondary Outcomes (1)
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.
11 weeks
Study Arms (2)
naproxcinod 375 mg - 750 mg -1125 mg bid
EXPERIMENTALdose escalating
naproxen 250 mg -500 mg -750 mg bid
ACTIVE COMPARATORdose escalating
Interventions
naproxcinod 375 mg -750 mg -1125 mg bid
naproxen 250 mg - 500mg -750 mg bid
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Study Sites (29)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Buena Park, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Stockbridge, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Newburgh, Indiana, United States
Unknown Facility
Terre Haute, Indiana, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Billings, Montana, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Edison, New Jersey, United States
Unknown Facility
Binghamton, New York, United States
Unknown Facility
Johnson City, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Clarksville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 16, 2008
First Posted
April 21, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2008
Study Completion
November 1, 2008
Last Updated
June 17, 2011
Record last verified: 2011-06