Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Status: | Recruiting |
---|---|
Conditions: | High Cholesterol, Diabetes |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/23/2019 |
Start Date: | March 23, 2017 |
End Date: | May 2022 |
Contact: | Senior Clinical Research Associate |
Email: | Clinical@KowaUS.com |
Phone: | 919-433-1600 |
The primary objective of the study is to determine whether pemafibrate administered twice
daily will delay the time to first occurrence of any component of the clinical composite
endpoint of:
- nonfatal Myocardial Infarction (MI)
- nonfatal ischemic stroke
- hospitalization for unstable angina requiring unplanned coronary revascularization; or
- Cardio Vascular (CV) death.
daily will delay the time to first occurrence of any component of the clinical composite
endpoint of:
- nonfatal Myocardial Infarction (MI)
- nonfatal ischemic stroke
- hospitalization for unstable angina requiring unplanned coronary revascularization; or
- Cardio Vascular (CV) death.
A multi-regional clinical trial with participating sites planned in the following countries
pending approval from the applicable oversight authorities:
- 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
pending approval from the applicable oversight authorities:
- 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
Inclusion Criteria:
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)
Exclusion Criteria:
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
4. Type 1 diabetes mellitus
We found this trial at
246
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
![University of Maryland School of Medicine](/wp-content/uploads/logos/university-of-maryland-school-of-medicine.jpg)
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Burlington, North Carolina 27215
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