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

Use our guide to learn which trials are right for you!

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.

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

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
sites
6280 Jackson Drive
San Diego, California 92119
?
mi
from
San Diego, CA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Ste 205, 10796 Pines Boulevard
Pembroke Pines, Florida 33026
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
1999 Marcus Avenue
Alhambra, California 91801
?
mi
from
Alhambra, CA
Click here to add this to my saved trials
?
mi
from
Anderson, IN
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheboro, North Carolina 27203
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
11220 Elm Lane
Asheville, North Carolina 28803
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Athens, OH
Click here to add this to my saved trials
5250 Leetsdale Drive
Aurora, Colorado 80012
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21228
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bay Pines, Florida 33744
?
mi
from
Bay Pines, FL
Click here to add this to my saved trials
Birmingham, Alabama 35235
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Buckley, Michigan 49620
?
mi
from
Buckley, MI
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burke, Virginia 22015
?
mi
from
Burke, VA
Click here to add this to my saved trials
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Cadillac, Michigan 49601
?
mi
from
Cadillac, MI
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charleston, South Carolina 29401
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
2205 McCallie Avenue
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
6035 Shallowford Road
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesapeake, Virginia 23321
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Chicago, Illinois 60616
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Collierville, Tennessee 38017
?
mi
from
Collierville, TN
Click here to add this to my saved trials
Costa Mesa, California 92627
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Council Bluffs, Iowa 51501
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Covington, Louisiana 70433
?
mi
from
Covington, LA
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
Cumming, Georgia 30041
?
mi
from
Cumming, GA
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75208
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32114
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
15300 Jog Road
Delray Beach, Florida 33446
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Dunwoody, Georgia 30338
?
mi
from
Dunwoody, GA
Click here to add this to my saved trials
11 Meridian Road
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
Edinburg, Texas 78539
?
mi
from
Edinburg, TX
Click here to add this to my saved trials
200 North Bryant Avenue
Edmond, Oklahoma 73034
?
mi
from
Edmond, OK
Click here to add this to my saved trials
Erie, Pennsylvania 16508
?
mi
from
Erie, PA
Click here to add this to my saved trials
Escondido, California 92026
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Evansville, Indiana 47713
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Farmington, Utah 84025
?
mi
from
Farmington, UT
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Feasterville, Pennsylvania 19053
?
mi
from
Feasterville, PA
Click here to add this to my saved trials
?
mi
from
Flint, MI
Click here to add this to my saved trials
Flossmoor, Illinois 60422
?
mi
from
Flossmoor, IL
Click here to add this to my saved trials
Flushing, New York 11355
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Fort Worth, Texas 76107
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fort Worth, Texas 76164
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Franklin, Ohio 45005
?
mi
from
Franklin, OH
Click here to add this to my saved trials
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Glendale, Arizona 85306
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greensboro, North Carolina 27408
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27410
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Gulf Shores, Alabama 36542
?
mi
from
Gulf Shores, AL
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
Haverhill, Massachusetts 01830
?
mi
from
Haverhill, MA
Click here to add this to my saved trials
Herndon, Virginia 20171
?
mi
from
Herndon, VA
Click here to add this to my saved trials