NL-OMON48935
Completed
Phase 3
A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) - MDCO-PCS-17-03 (ORION-9)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- hypercholesterolemia and elevated levels of cholesterol
- Sponsor
- The Medicines Company
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects may be included in the study if they meet all of the following
- •1\. Male or female subjects \*18 years of age.
- •2\. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a
- •documented history of untreated LDL\-C of \>190 mg/dL, and a family history of
- •FH, elevated cholesterol or early heart disease may indicate FH
- •3\. Stable on a low\-fat diet (eg, NCEP)
- •4\. Serum LDL\-C \*2\.6 mmol/L (\*100 mg/dL) at screening
- •5\. Fasting triglyceride \<4\.52 mmol/L (\<400 mg/dL) at screening.
- •6\. Calculated glomerular filtration rate \>30 mL/min by estimated glomerular
- •filtration rate (eGFR) using standardized clinical methodology.
Exclusion Criteria
- •Subjects will be excluded from the study if any of the following exclusion
- •criteria apply prior to randomization:
- •1\. Any uncontrolled or serious disease, or any medical or surgical condition,
- •that may either interfere with participation in the clinical study, and/or put
- •the subject at significant risk (according to investigator's \[or delegate]
- •judgment) if he/she participates in the clinical study.
- •2\. An underlying known disease, or surgical, physical, or medical condition
- •that, in the opinion of the investigator (or delegate) might interfere with
- •interpretation of the clinical study results.
- •3\. New York Heart Association (NYHA) class IV heart failure or last known left
Outcomes
Primary Outcomes
Not specified
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