Clinical trials: Hypobetalipoproteinemia
Hypercholesterolemia
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use…
- Trial name
- FUTURA (NCT00526058)
- Testing
- Secura then Futura, Futura then Secura
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- B. Braun Medical Inc.
Healthy
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; [2-hour infusion]) supra-therapeutic dose relative to placebo in healthy adult male…
- Trial name
- NCT01090661
- Testing
- mipomersen sodium, moxifloxacin hydrochloride (Avelox®)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC
Healthy Volunteer
A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for coronary heart disease (CHD).
- Trial name
- NCT01061814
- Testing
- mipomersen
- Where
- Canada
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC
Healthy Volunteer
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels.
- Trial name
- NCT01414881
- Testing
- mipomersen
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC
Type 2 Diabetes
A Diabetes Study to Treat A Population Previously Not at Target
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step…
- Trial name
- ADAPT (NCT00747149)
- Testing
- Rosuvastatin
- Where
- 84 sites in Canada
- Volunteers
- 598 people
- Sponsor
- AstraZeneca
Healthy
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin
The purpose of this study is to assess how blood clotting and thinning time is effected when a single dose of warfarin is given alone and when a single dose of warfarin is given with mipomersen; to assess the blood levels of a…
- Trial name
- NCT01133366
- Testing
- warfarin sodium, mipomersen sodium; warfarin sodium
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC
Lipid Metabolism, Inborn Errors, Hyperlipidemias
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis.
- Conditions
- Lipid Metabolism, Inborn Errors, Hyperlipidemias, Metabolic Diseases, Hypolipoproteinemia
- Trial name
- NCT00362180
- Testing
- mipomersen
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC