| 1 |
NCT01598948 |
Completed |
Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis |
- Atherosclerosis
- LDL-hypercholesterolemia
|
|
Interventional
|
Phase 3 |
- Ludwig-Maximilians - University of Munich
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in pre-apheresis LDL-cholesterol (phase 1 of the study)
- Fraction of patients in whom apheresis conditions can be modified (phase 2 of the study)
- change in other lipid parameters
- (and 2 more...)
|
17 |
All |
18 Years and older (Adult, Older Adult) |
NCT01598948 |
MICA |
MICA |
August 2012 |
May 2015 |
June 2015 |
May 15, 2012 |
September 2, 2015 |
|
- University Munich
Munich, Germany
|
|
| 2 |
NCT00477594 |
Completed
Has Results |
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia |
- Lipid Metabolism, Inborn Errors
- Hypercholesterolemia, Autosomal Dominant
- Hyperlipidemias
- (and 11 more...)
|
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
- Low-density Lipoprotein Cholesterol (LDL-C) Over Time
- Percent Change From Baseline in Apolipoprotein B
- (and 11 more...)
|
21 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00477594 |
301012-CS17
2007-001024-12 |
|
May 2007 |
March 2011 |
July 2011 |
May 24, 2007 |
September 9, 2016 |
April 5, 2013 |
- Chicago, Illinois, United States
- Auburn, Maine, United States
- Biddeford, Maine, United States
- (and 2 more...)
|
|
| 3 |
NCT01414881 |
Completed |
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects |
|
- Drug: mipomersen
- Drug: Placebo
|
Interventional
|
Phase 1 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
|
- Percent change in the production rate (PR) of very low density lipoprotein (VLDL) apolipoprotein B (apo B)
- Fractional clearance rate (FCR) of VLDL Triglyceride (TG), VLDL apo B, intermediate density lipoprotein (IDL) apo B, and low-density lipoprotein (LDL) apo B
- Production rate (PR) of VLDL-TG, IDL apo B, LDL apo B
- (and 5 more...)
|
20 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01414881 |
MIPO1600810 |
|
September 2011 |
June 2012 |
November 2012 |
August 11, 2011 |
August 3, 2016 |
|
- Columbia-Presbyterian Medical Center, MS Care Center
New York, New York, United States
|
|
| 4 |
NCT01475825 |
Completed
Has Results |
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 |
- Hypercholesterolemia
- Heterozygous Familial
|
- Drug: mipomersen sodium 200 mg
- Drug: Placebo
- Drug: mipomersen sodium 70 mg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline To Primary Endpoint Visit (PET) In LDL-C In Cohort 1
- Percent Change From Baseline To PET In LDL-C In Cohort 2
- Percent Change From Baseline To PET In Apolipoprotein B (Apo B) In Cohort 1
- (and 3 more...)
|
309 |
All |
18 Years and older (Adult, Older Adult) |
NCT01475825 |
MIPO3801011
2011-001480-42
EFC12875 |
FOCUS FH |
December 2011 |
December 29, 2015 |
December 29, 2015 |
November 21, 2011 |
March 26, 2019 |
March 14, 2019 |
- Mission Viejo, California, United States
- Aurora, Colorado, United States
- Cooper City, Florida, United States
- (and 113 more...)
|
|
| 5 |
NCT00607373 |
Completed
Has Results |
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia |
- Lipid Metabolism, Inborn Errors
- Hypercholesterolemia, Autosomal Dominant
- Hyperlipidemias
- (and 11 more...)
|
- Drug: mipomersen
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point
- LDL-C at Baseline and the Primary Efficacy Time Point (PET)
- Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point
- (and 5 more...)
|
51 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00607373 |
301012CS5
2005-003449-15 |
RADICHOL 1 |
July 2007 |
March 2009 |
March 2009 |
February 5, 2008 |
September 9, 2016 |
March 21, 2013 |
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Sao Paulo, SP, Brazil
- (and 7 more...)
|
|
| 6 |
NCT00770146 |
Completed
Has Results |
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients |
- Hypercholesterolemia
- Coronary Heart Disease
|
- Drug: Mipomersen sodium
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point
- Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point
- Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point
- (and 5 more...)
|
158 |
All |
18 Years and older (Adult, Older Adult) |
NCT00770146 |
301012-CS12 |
|
November 2008 |
May 2010 |
October 2010 |
October 9, 2008 |
September 9, 2016 |
March 20, 2013 |
- Birmingham, Alabama, United States
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- (and 59 more...)
|
|
| 7 |
NCT00694109 |
Completed
Has Results |
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 |
- Lipid Metabolism, Inborn Errors
- Hypercholesterolemia, Autosomal Dominant
- Hyperlipidemias
- (and 11 more...)
|
|
Interventional
|
Phase 3 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
- Percent Change From Baseline in Apolipoprotein B (Apo B)
- Percent Change From Baseline in Total Cholesterol
- (and 18 more...)
|
144 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00694109 |
301012-CS6
2005-003450-10 |
|
April 2008 |
September 2014 |
September 2014 |
June 10, 2008 |
September 9, 2016 |
December 21, 2015 |
- Mission Viejo, California, United States
- Newport Beach, California, United States
- Bridgeport, Connecticut, United States
- (and 30 more...)
|
|
| 8 |
NCT01133366 |
Completed |
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin |
|
- Drug: warfarin sodium
- Drug: mipomersen sodium; warfarin sodium
|
Interventional
|
Phase 1 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the effect curve (AUC), for INR (international normalized ratio), PT (prothrombin time), and aPTT (activated partial thromboplastin time)
- Maximal Value (MAX) for INR, PT and aPTT
- Time of maximal effect (Tmax) for INR, PT, and aPTT
- (and 3 more...)
|
18 |
All |
18 Years to 45 Years (Adult) |
NCT01133366 |
MIPO2900509 |
|
May 2010 |
May 2010 |
July 2010 |
May 28, 2010 |
August 3, 2016 |
|
- PPD Development, LP
Austin, Texas, United States
|
|
| 9 |
NCT00794664 |
Completed
Has Results |
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis |
- Hypercholesterolemia
- Coronary Heart Disease
|
- Drug: Mipomersen
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point
- LDL-C at Baseline and the Primary Efficacy Time Point (PET)
- Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point
- (and 5 more...)
|
58 |
All |
18 Years and older (Adult, Older Adult) |
NCT00794664 |
MIPO3500108
2008-006020-53 |
|
January 2009 |
May 2010 |
October 2010 |
November 20, 2008 |
September 9, 2016 |
March 21, 2013 |
- Jupiter, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- (and 24 more...)
|
|
| 10 |
NCT01061814 |
Completed |
A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers |
|
- Drug: mipomersen
- Drug: Placebo
|
Interventional
|
Phase 1 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of treatment-emergent AEs and SAEs
- Maximum plasma concentration (Cmax)
- time to maximal concentration (Tmax)
- area under the curve (AUC) based on PK profiles following the first and last dose
|
84 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01061814 |
MIPO3200309 |
|
January 2010 |
March 2010 |
June 2010 |
February 3, 2010 |
August 3, 2016 |
|
- Anapharm, Inc.
Montreal,, Quebec, Canada
|
|
| 11 |
NCT01299298 |
Completed |
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers |
|
- Drug: mipomersen
- Drug: placebo
|
Interventional
|
Phase 1 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Maximum plasma concentration (Cmax)
- Time to maximal concentration (Tmax)
- Area Under the Curve (AUC)
- Number of Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
20 |
Male |
20 Years to 45 Years (Adult) |
NCT01299298 |
MIPO3700710
2010-021948-18 |
|
January 2011 |
April 2011 |
April 2011 |
February 18, 2011 |
August 3, 2016 |
|
- FOCUS Clinical Drug Development GmbH
Stresemannallee 6, Neuss, Germany
|
|
| 12 |
NCT00706849 |
Completed
Has Results |
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease |
- Heterozygous Familial Hypercholesterolemia
- Coronary Artery Disease
|
- Drug: mipomersen sodium
- Drug: placebo
|
Interventional
|
Phase 3 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point
- LDL Cholesterol at Baseline and at the Primary Efficacy Time Point
- Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point
- (and 5 more...)
|
124 |
All |
18 Years and older (Adult, Older Adult) |
NCT00706849 |
301012-CS7 |
RADICHOL II |
July 2008 |
December 2009 |
May 2010 |
June 30, 2008 |
September 9, 2016 |
March 21, 2013 |
- La Jolla, California, United States
- Los Angeles, California, United States
- Mission Viejo, California, United States
- (and 45 more...)
|
|
| 13 |
NCT01090661 |
Completed |
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects |
|
- Drug: mipomersen sodium
- Drug: moxifloxacin hydrochloride (Avelox®)
- Drug: placebo
|
Interventional
|
Phase 1 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- change from baseline in QTcF (corrected Frederica's CT interval)
- ECG intervals (QTcB (corrected Bazett's QT interval), HR (heart rate, PR, QRS, and QT)
- change in ECG morphological patterns
- (and 3 more...)
|
60 |
All |
18 Years to 45 Years (Adult) |
NCT01090661 |
MIPO2800209 |
|
March 2010 |
May 2010 |
May 2010 |
March 22, 2010 |
August 3, 2016 |
|
- PPD Development, LP
Austin, Texas, United States
|
|
| 14 |
NCT00707746 |
Completed
Has Results |
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects |
- Metabolic Diseases
- Hyperlipidemias
- Metabolic Disorder
- (and 3 more...)
|
- Drug: mipomersen
- Drug: placebo
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point
- Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point
- Summary of Participants With Adverse Events
- (and 6 more...)
|
34 |
All |
18 Years and older (Adult, Older Adult) |
NCT00707746 |
301012-CS19
2007-005140-24 |
ASSIST |
October 2008 |
August 2010 |
January 2011 |
July 1, 2008 |
September 9, 2016 |
April 5, 2013 |
|
|
| 15 |
NCT00362180 |
Completed
Has Results |
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration |
- Lipid Metabolism, Inborn Errors
- Hyperlipidemias
- Metabolic Diseases
- (and 11 more...)
|
- Drug: mipomersen
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)
- Baseline Apolipoprotein B
- Percent Change in Apolipoprotein B From Baseline to Day 99
- (and 4 more...)
|
38 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00362180 |
301012-CS10
2005-005783-90 |
|
July 2006 |
March 2010 |
September 2010 |
August 9, 2006 |
October 21, 2016 |
June 24, 2015 |
|
|
| 16 |
NCT00281008 |
Completed |
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy |
- Hypercholesterolemia, Familial
|
- Drug: ISIS 301012 or Placebo
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent reduction in LDL-cholesterol from baseline
|
44 |
All |
18 Years and older (Adult, Older Adult) |
NCT00281008 |
301012CS9
2005-004797-24 |
|
February 2006 |
July 2007 |
December 2007 |
January 24, 2006 |
August 3, 2016 |
|
- Chicago, Illinois, United States
- Auburn, Maine, United States
- Scarborough, Maine, United States
- (and 5 more...)
|
|
| 17 |
NCT00280995 |
Completed |
Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy |
- Hypercholesterolemia, Familial
|
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent reduction in LDL-cholesterol from baseline
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT00280995 |
301012CS8
EudraCT No.: 2005-004796-38 |
|
January 2006 |
April 2007 |
August 2007 |
January 24, 2006 |
August 3, 2016 |
|
- Chicago, Illinois, United States
- New York City, New York, United States
- Winston-Salem, North Carolina, United States
- (and 3 more...)
|
|
| 18 |
NCT00231569 |
Completed |
Dose-escalating Safety Study in Subjects on Stable Statin Therapy |
|
- Drug: ISIS 301012 or Placebo
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent reduction in LDL-cholesterol from baseline
- Percent reduction in apoB-100
- Percent change in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL plus LDL-cholesterol and LDL-cholesterol particle size and concentration
- (and 2 more...)
|
74 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00231569 |
301012CS4
EudraCT No.: 2005-002119-26 |
|
September 2005 |
June 2007 |
December 2007 |
October 4, 2005 |
August 3, 2016 |
|
- Auburn, Maine, United States
- Amsterdam, Netherlands
- Leiden, Netherlands
- (and 2 more...)
|
|
| 19 |
NCT00216463 |
Completed |
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels |
|
- Drug: ISIS 301012 or Placebo
|
Interventional
|
Phase 2 |
- Kastle Therapeutics, LLC
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent reduction in LDL-cholesterol from baseline
- Percent reduction in apoB-100 from baseline
- Percent change from baseline in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL and LP(a)
- Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios
|
50 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00216463 |
301012CS3
EudraCT No.: 2004-003934-32 |
|
August 2005 |
March 2007 |
August 2007 |
September 22, 2005 |
August 3, 2016 |
|
|
|
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