Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
NCT00943306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2018-06-13
Summary
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
Conditions
- Familial Hypercholesterolemia
Interventions
- DRUG
-
lomitapide
5-60 mg po every day
Sponsors & Collaborators
-
Aegerion Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Marina Cuchel, MD, PhD · University of Pennsylvania
-
Mark Sumeray, MD · Aegerion Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-29
- Primary Completion
- 2012-09-17
- Completion
- 2014-12-01
Countries
- United States
- Canada
- Italy
- South Africa
Study Locations
More Related Trials
-
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
NCT06832371 ·Status: ACTIVE_NOT_RECRUITING
-
Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
NCT02080455 ·Status: COMPLETED ·Phase: PHASE1
-
LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT02135705 ·Status: COMPLETED
-
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
NCT00694109 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH)
NCT00730236 ·Status: COMPLETED ·Phase: PHASE3
-
Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
NCT00079846 ·Status: TERMINATED ·Phase: PHASE2
-
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
NCT01190007 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
NCT00707746 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
NCT00477594 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
NCT00559962 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
NCT00301366 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
NCT01475825 ·Status: COMPLETED ·Phase: PHASE3
-
Influence of Simvastatin on Apolipoprotein B-100 (apoB-100) Secretion
NCT00905541 ·Status: COMPLETED ·Phase: NA
-
A Study of LY3015014 in Healthy Participants With High Cholesterol
NCT01671085 ·Status: COMPLETED ·Phase: PHASE1
-
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
NCT00362180 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
NCT03156621 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
NCT02941848 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
NCT00530946 ·Status: COMPLETED ·Phase: PHASE3
-
Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )
NCT00408057 ·Status: COMPLETED
-
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
NCT01841684 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
NCT00794664 ·Status: COMPLETED ·Phase: PHASE3
-
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
NCT00281008 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of LY3015014 in Participants With High Cholesterol
NCT01890967 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
NCT01709500 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
NCT02107898 ·Status: COMPLETED ·Phase: PHASE3