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Sponsored by: |
NicOx |
---|---|
Information provided by: | NicOx |
ClinicalTrials.gov Identifier: | NCT00662896 |
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, naproxen, ibuprofen |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 300 |
Study Start Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
naproxcinod: Active Comparator
375mg, 750mg bid
|
Drug: naproxcinod, naproxen, ibuprofen
naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg
|
naproxen: Active Comparator
250mg, 500mg bid
|
Drug: naproxcinod, naproxen, ibuprofen
naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg
|
ibuprofen: Active Comparator
600mg tid
|
Drug: naproxcinod, naproxen, ibuprofen
naproxcinod: 375mg, 750mg, naproxen: 250mg, 500mg, ibuprofen: 600mg
|
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NicOx. ( NicOx ) |
Study ID Numbers: | HCT 3012-X-112 |
Study First Received: | April 16, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00662896 |
Health Authority: | United States: Food and Drug Administration |
Nitric Oxide Ibuprofen Naproxen Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Vascular Diseases Naproxen-n-butyl nitrate Essential hypertension Rheumatic Diseases Hypertension |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Gout Suppressants Pharmacologic Actions Nitric Oxide Donors |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |