15 completed, 2 withdrawn, 1 terminated. 5 Phase 1, 5 Phase 2, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 2 | 5 | Completed 5 |
| Phase 3 | 5 | Completed 4, Withdrawn 1 |
Follow BMS201038: new trials by email Literature Review of BMS201038 trials Research Report on BMS201038
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH) Lomitapide - Homozygous Familial Hypercholesterolaemia (HoFH) | Phase 3 | Completed | Amryt Pharma | 46 | 2020-12-14 | 2025-08-27 |
| Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy Lomitapide - Homozygous Familial Hypercholesterolemia | Phase 3 | Withdrawn | Aegerion Pharmaceuticals, Inc. | 2016-05-01 | 2018-02-22 | |
| Effects of Lomitapide on Carotid and Aortic Atherosclerosis Lomitapide - Homozygous Familial Hypercholesterolemia | Withdrawn | Aegerion Pharmaceuticals, Inc. | 2015-06-01 | 2017-12-15 | ||
| Global Lomitapide Pregnancy Exposure Registry lomitapide - Pregnancy | Terminated | Amryt Pharma | 5 | 2014-10-01 | 2022-12-16 | |
| Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy lomitapide - Familial Hypercholesterolemia - Homozygous | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 9 | 2014-04-02 | 2018-10-10 |
| LOWER: Lomitapide Observational Worldwide Evaluation Registry Lomitapide - Homozygous Familial Hypercholesterolemia | Completed | Amryt Pharma | 260 | 2014-03-18 | 2026-05-12 | |
| Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects lomitapide, EE/norgestimate - Healthy | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2014-02-19 | 2019-03-11 |
| Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects. lomitapide, Atorvastatin - Effect of Atorvastatin on the Pharmacokinetics of Lomitapide | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2014-01-27 | 2020-03-10 |
| A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled lomitapide - Healthy | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 32 | 2013-10-30 | 2018-02-13 |
| Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects lomitapide - Intra-subject Variability of Pharmacokinetics | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 15 | 2013-07-29 | 2020-03-11 |
| Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C lomitapide - Healthy Volunteer | Phase 1 | Completed | Aegerion Pharmaceuticals, Inc. | 72 | 2012-11-07 | 2018-11-20 |
| Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia lomitapide - Familial Hypercholesterolemia | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 19 | 2009-10-29 | 2018-06-13 |
| Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia Atorvastatin, AEGR-733 - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 44 | 2008-05-01 | 2018-02-23 |
| A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH) AEGR-733 - Homozygous Familial Hypercholesterolemia | Phase 3 | Completed | Aegerion Pharmaceuticals, Inc. | 29 | 2007-12-01 | 2018-03-20 |
| Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS AEGR-733, placebo, AEGR-733 and atorvastatin - Hyperlipidemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 260 | 2007-10-01 | 2018-02-23 |
| AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia Atorvastatin 20 mg, AEGR-733 5 mg, AEGR-733 10 mg - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 157 | 2007-04-01 | 2018-03-20 |
| The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia BMS-201038 (AEGR-733), Ezetimibe - Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 60 | 2006-05-01 | 2014-03-04 |
| Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor Lomitapide - Homozygous Familial Hypercholesterolemia | Phase 2 | Completed | Aegerion Pharmaceuticals, Inc. | 6 | 2003-06-01 | 2013-04-10 |
Homozygous Familial Hypercholesterolemia (8) · Hypercholesterolemia (4) · Hyperlipidemias (2) · Hyperlipoproteinemia Type II (1)
Aegerion Pharmaceuticals, Inc. (15) · Amryt Pharma (3)
United States (10) · Italy (4) · United Kingdom (4) · Canada (3) · Germany (2) · South Africa (2) · Argentina (1) · France (1) · Greece (1) · Israel (1) · Japan (1) · Netherlands (1) · Saudi Arabia (1) · Spain (1) · Tunisia (1)
Mark Sumeray, MD (6) · Marina Cuchel, MD, PhD (2) · T. Alex King, MD, CPI (2) · Ulrike Lorch, MD (2) · Barry Lubin, MD (1) · Dan J Rader, MD (1) · Eli Roth, MD (1) · Jackson Downey, MD (1) · James McKenney, Pharm D (1) · Janet Boylan (1) · Mariko Harada-Shiba, M.D., Ph.D. (1) · Michael Davidson, MD (1) · Paul Grena, MD (1) · Qing Chang, MD (1) · Sallyann O'Brien (1)
PMID 36520008, PMID 17215532, PMID 25897792, PMID 26723464, PMID 30663562, PMID 39426393, PMID 42613196