NL-OMON39914
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to evaluate the Efficacy and Safety of SAR236553 (REGN727) in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C higher or equal to 160mg/dL with Their Lipid-Modifying Therapy - EFC12732 / Odyssey High FH
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- familial hypercholesterolemia
- Sponsor
- Sanofi-aventis
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid\-modifying therapy.
Exclusion Criteria
- •\- Age \< 18 years;\- LDL\-C \< 160 mg/dL (\< 4\.14 mmol/L) at the screening visit (Week\-2\).;\- Fasting serum triglycerides \> 400 mg/dL (\> 4\.52 mmol/L) during the screening period.;\- Known history of homozygous familial hypercholesterolemia.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727/Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapyfamilial hypercholesterolemiainherited hyperlipidemia100274241001331710003216NL-OMON39858Sanofi-aventis18
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid-Modifying Therapyfamilial hyperchomesterolemiainherited hyperlipidemia100274241001331710003216NL-OMON39622Regeneron Pharmaceuticals, Inc.100
Completed
Phase 3
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, 12-Week Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood P/266/2011, P267/2011, P268/2011hyperlipidemiehigh cholesterolHyperlipidaemiaNL-OMON37577Kowa Research Europe40
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemiahypertriglyceridemia10013317NL-OMON43654IONIS Pharmaceuticals, Inc6
Completed
Phase 4
A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)inflamatory bowel diseaseUlcerative Colitis10017969NL-OMON47815Takeda Development Centre Europe, Ltd10