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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- NicOx
- 入组人数
- 300
- 主要终点
- 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.
研究概览
简要总结
To assess the effect of naproxcinod vs. naproxen and ibuprofen on arterial blood pressure in patients with osteoarthritis and controlled essential hypertension
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
naproxcinod 375 mg bid
干预措施: naproxcinod 375 mg bid (Drug)
naproxen 250 mg bid
干预措施: naproxen 250 mg bid (Drug)
ibuprofen 600 mg tid
干预措施: ibuprofen 600 mg tid (Drug)
naproxcinod 750 mg bid
干预措施: naproxcinod 750 mg bid (Drug)
naproxen 500 mg bid
干预措施: naproxen 500 mg bid (Drug)
结局指标
主要结局
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.
时间窗: 15 weeks
次要结局
- 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.(15 weeks)
- To assess the general safety and tolerability of naproxcinod compared to naproxen and ibuprofen.(15 weeks)