EUCTR2012-000872-40-CZ
Active, not recruiting
Not Applicable
A pilot study to assess the efficacy and safety of LCQ908 alone and in combination with fenofibrate or Lovaza® in patients with severe hypertriglyceridemia
Conditionson Familial Chylomicronemia Syndrome (Non-FCS)MedDRA version: 14.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Non Familial Chylomicronemia Syndrome (Non-FCS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on Familial Chylomicronemia Syndrome (Non-FCS)
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male and female subjects ages \>18 years of age, inclusive.
- •\-History of plasma TG concentration \>\=890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
- •\-Fasting TG \>\= 750 mg/dL (8\.5 mmol/L) at day \-7 or repeat of day \-7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 5
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 5
- •\-Male and female subjects ages \>18 years of age, inclusive.
Exclusion Criteria
- •\-Treatment with Omega\-3 fatty acids or niacin or fibrates within 8 weeks of screening.
- •\-Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type\-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I\-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1\) prior to screening.
- •\-Pancreatitis within 3 months prior to screening.
- •\-Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of \=8\.0% at screening)
- •\-BMI \> 40 or history of bariatric surgery.
- •\-Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
- •\-Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1\.73m2
- •\-History of known allergy to fish/shellfish or any of the ingredients in Lovaza
- •\-Heart transplant recipients, participants with implantable cardioverter defibrillators with ventricular tachycardia or ventricular arrhythmia, or participants with very significant cardiovascular disease, as determined by the investigator
- •\-Treatment with Omega\-3 fatty acids or niacin or fibrates within 8 weeks of screening.
Outcomes
Primary Outcomes
Not specified
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