CTRI/2017/07/009172Other3 期
Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes (PROMINENT) - Nil
Kowa Research Institute Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Fasting TG ââ?°Â¥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1
- •(Screening/Enrollment Visit) or Visit 1.1 (Retest)
- •2. HDL-C ââ?°Â¤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1
- •3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c
- •(ââ?°Â¥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ââ?°Â¥ 126 mg/dL [7.0 mmol/L],
- •2-hour ââ?°Â¥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ââ?°Â¥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either;
- •a) Age ââ?°Â¥ 50 years if male or ââ?°Â¥ 55 years if female (primary prevention cohort), OR
- •b) Age ââ?°Â¥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:
- •i. Prior MI or ischemic (non-hemorrhagic) stroke
- •ii. Coronary angiographic lesion of ââ?°Â¥ 60% stenosis in a major epicardial vessel or ââ?°Â¥ 50% left main stenosis
- •iii. Asymptomatic carotid disease with ââ?°Â¥ 70% carotid artery stenosis
- •iv. Symptomatic carotid disease with ââ?°Â¥ 50% carotid artery stenosis
- •v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ââ?°Â¤ 0.9 or other diagnostic testing [toe-brachial index, angiogram, or other imaging study])
- •vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)
排除标准
- •1. Current or planned use of fibrates or agents with PPAR-Ã?± agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit).
- •PPAR-Ã?³ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
- •2. Known sensitivity to PPAR-Ã?± agonists or tablet excipients
- •3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day
- •4. Type 1 diabetes mellitus
研究者
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