Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kowa Research Institute, Inc.
With
Brigham and Women's Hospital
A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements.
* Argentina
* Brazil
* Bulgaria
* Canada
* Colombia
* Czech Republic
* Denmark
* France
* Germany
* Hungary
* India
* Israel
* Japan
* Mexico
* Netherlands
* Poland
* Romania
* Russian Federation
* Slovakia
* South Africa
* Spain
* Ukraine
* United Kingdom
* United States
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Fasting TG ≥ 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 ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
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 (≥ 6.5% \[48 mmol/mol\]), elevated plasma glucose (fasting ≥ 126 mg/dL \[7.0 mmol/L\], 2-hour ≥ 200 mg/dL \[11.1 mmol/L\] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either
1. Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
2. Age ≥ 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 ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
* iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
* iv. Symptomatic carotid disease with ≥ 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 ≤ 0.9 or other diagnostic testing \[eg, toe-brachial index, angiogram, or other imaging study\])
* vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)
You may not be if
1. Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
2. Known sensitivity to PPAR-α 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
