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Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) (PROMINENT)

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ClinicalTrials.gov Identifier: NCT03071692
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dyslipidemia Drug: K-877 Drug: Placebo Phase 3

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
K-877 (pemafibrate) tablet twice daily.
Drug: K-877
0.2mg tablet
Other Name: pemafibrate

Placebo Comparator: Control Group
Matching K-877 placebo tablet twice daily.
Drug: Placebo
K-877 matching placebo tablet




Primary Outcome Measures :
  1. Number of patients with first occurrence of nonfatal MI, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or CV death. [ Time Frame: Through study completion, an average of 4 years ]
    Number of patients with first occurrence of nonfatal MI, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or CV death.


Secondary Outcome Measures :
  1. Time to first occurrence of any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death [ Time Frame: Through study completion, an average of 4 years ]

    Time to first occurrence of:

    Any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death


  2. Time to first occurrence of any component of the primary endpoint or hospitalization for Heart failure (HF) [ Time Frame: Through study completion, an average of 4 years ]

    Time to first occurrence of:

    Any component of the primary endpoint or hospitalization for Heart failure (HF)


  3. Time to first occurrence of any component of the primary endpoint or all-cause mortality [ Time Frame: Through study completion, an average of 4 years ]

    Time to first occurrence of:

    Any component of the primary endpoint or all-cause mortality


  4. Time to first occurrence of any component of the primary endpoint, any coronary revascularization, or hospitalization for HF [ Time Frame: Through study completion, an average of 4 years ]

    Time to first occurrence of:

    Any component of the primary endpoint, any coronary revascularization, or hospitalization for HF


  5. Time to first occurrence of any new or worsening Peripheral artery disease (PAD) [ Time Frame: Through study completion, an average of 4 years ]

    Time to first occurrence of:

    Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, 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)


  6. Lipid Endpoints [ Time Frame: Week -3 to Month 4 (Visit 1 to Visit 5) ]
    The change from Screening/Enrollment Visit (Visit 1) to Month 4 Visit (Visit 5) for the following lipid biomarkers: Total cholesterol (TC), Triglyceride(s) (TG), High-density lipoprotein cholesterol (HDL-C), non-HDL-C (calculated), Very low-density lipoprotein cholesterol (VLDL-C) (calculated), ApoA1, ApoC3, and ApoE

  7. Nonfasting Remnant Cholesterol Endpoint [ Time Frame: Week 0 to Month 6 (Visit 2 to Visit 6) ]
    The change from Randomization Visit (Visit 2) to Month 6 Visit (Visit 6) for nonfasting remnant cholesterol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071692


Contacts
Contact: Senior Clinical Research Associate 919-433-1600 Clinical@KowaUS.com

  Show 769 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Brigham and Women's Hospital
Investigators
Study Director: Paul Ridker, MD CCVDP & The Brigham and Women's Hospital
Study Director: Aruna Pradhan, MD CCVDP & The Brigham and Women's Hospital

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03071692     History of Changes
Other Study ID Numbers: K-877-302
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders