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:
NicOx
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00662896
First received: April 16, 2008
Last updated: June 16, 2011
Last verified: June 2011
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Purpose
To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Hypertension |
Drug: naproxcinod 375 mg bid Drug: naproxcinod 750 mg bid Drug: naproxen 250 mg bid Drug: naproxen 500 mg bid Drug: ibuprofen 600 mg tid |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Drug Information available for:
Ibuprofen
Naproxen
Naproxen sodium
Ibuprofen sodium
Ibuprofen lysinate
U.S. FDA Resources
Further study details as provided by NicOx:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: naproxcinod 375 mg bid |
Drug: naproxcinod 375 mg bid
naproxcinod 375 mg bid
|
| Active Comparator: naproxen 250 mg bid |
Drug: naproxen 250 mg bid
naproxen 250 mg bid
|
| Active Comparator: ibuprofen 600 mg tid |
Drug: ibuprofen 600 mg tid
ibuprofen 600 mg tid
|
| Experimental: naproxcinod 750 mg bid |
Drug: naproxcinod 750 mg bid
naproxcinod 750 mg bid
|
| Active Comparator: naproxen 500 mg bid |
Drug: naproxen 500 mg bid
naproxen 500 mg bid
|
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662896
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| Sierra Vista, Arizona, United States | |
| United States, California | |
| Carmichael, California, United States | |
| Fair Oaks, California, United States | |
| Long Beach, California, United States | |
| Pico Rivera, California, United States | |
| Upland, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Farmington, Connecticut, United States | |
| Milford, Connecticut, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Clearwater, Florida, United States | |
| DeLand, Florida, United States | |
| Fort Myers, Florida, United States | |
| Gainesville, Florida, United States | |
| Jupiter, Florida, United States | |
| Kissimmee, Florida, United States | |
| Miami, Florida, United States | |
| Ormond Beach, Florida, United States | |
| Pembroke Pines, Florida, United States | |
| West Palm Beach, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Decatur, Georgia, United States | |
| Marietta, Georgia, United States | |
| United States, Illinois | |
| Arlington Heights, Illinois, United States | |
| Peoria, Illinois, United States | |
| United States, Kentucky | |
| Elizabethtown, Kentucky, United States | |
| Erlanger, Kentucky, United States | |
| United States, Louisiana | |
| Metairie, Louisiana, United States | |
| Shreveport, Louisiana, United States | |
| United States, Maine | |
| Auburn, Maine, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| Towson, Maryland, United States | |
| United States, Missouri | |
| Florissant, Missouri, United States | |
| United States, Montana | |
| Missoula, Montana, United States | |
| United States, Nebraska | |
| Grand Island, Nebraska, United States | |
| United States, Nevada | |
| Henderson, Nevada, United States | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| Concord, North Carolina, United States | |
| Hickory, North Carolina, United States | |
| Lenoir, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Havertown, Pennsylvania, United States | |
| Tipton, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Tennessee | |
| Kingsport, Tennessee, United States | |
| New Tazewell, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Irving, Texas, United States | |
| Longview, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
Sponsors and Collaborators
NicOx
More Information
Additional Information:
No publications provided
| Responsible Party: | NicOx, NicOx. |
| ClinicalTrials.gov Identifier: | NCT00662896 History of Changes |
| Other Study ID Numbers: | HCT 3012-X-112 |
| Study First Received: | April 16, 2008 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Osteoarthritis Vascular Diseases Cardiovascular Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Naproxen Ibuprofen Naproxen-n-butyl nitrate Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Nitric Oxide Donors Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013