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19 Studies found for: MIPOMERSEN

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NCT01598948

Completed

Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis

Atherosclerosis
LDL-hypercholesterolemia

Drug: mipomersen

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...)

All

18 Years and older (Adult, Older Adult)

NCT01598948

MICA

August 2012

May 2015

June 2015

May 15, 2012

September 2, 2015

University Munich
Munich, Germany

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...)

Drug: mipomersen sodium

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...)

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...)

NCT01414881

Completed

Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

Healthy Volunteer

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...)

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

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...)

All

12 Years and older (Child, Adult, Older Adult)

NCT00607373

301012CS5
2005-003449-15

RADICHOL 1

July 2007

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...)

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...)

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...)

Drug: Mipomersen Sodium

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

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...)

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

Healthy

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...)

All

18 Years to 45 Years (Adult)

NCT01133366

MIPO2900509

May 2010

July 2010

May 28, 2010

August 3, 2016

PPD Development, LP
Austin, Texas, United States

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...)

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...)

NCT01475825

Completed

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

Kastle Therapeutics, LLC

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) in Cohort 1
Percent Change from Baseline in Apolipoprotein B (Apo B)
Percent Change from Baseline in Lipoprotein a
Percent Change from Baseline in LDL-C in Cohort 2

310

All

18 Years and older (Adult, Older Adult)

NCT01475825

MIPO3801011
2011-001480-42
EFC12875

FOCUS FH

December 2011

February 2016

November 21, 2011

August 3, 2016

Mission Viejo, California, United States
Aurora, Colorado, United States
Cooper City, Florida, United States
(and 128 more...)

NCT01061814

Completed

A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers

Healthy Volunteer

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

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

NCT01299298

Completed

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers

Healthy Volunteer

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)

Male

20 Years to 45 Years (Adult)

NCT01299298

MIPO3700710
2010-021948-18

January 2011

April 2011

February 18, 2011

August 3, 2016

FOCUS Clinical Drug Development GmbH
Stresemannallee 6, Neuss, Germany

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...)

NCT01090661

Completed

A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects

Healthy

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...)

All

18 Years to 45 Years (Adult)

NCT01090661

MIPO2800209

March 2010

May 2010

March 22, 2010

August 3, 2016

PPD Development, LP
Austin, Texas, United States

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...)

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

Amsterdam, Netherlands

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...)

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

Amsterdam, Netherlands

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

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...)

NCT00280995

Completed

Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

Hypercholesterolemia, Familial

Drug: ISIS 301012

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

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...)

NCT00231569

Completed

Dose-escalating Safety Study in Subjects on Stable Statin Therapy

Hypercholesterolemia

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...)

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...)

NCT00216463

Completed

Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

Hypercholesterolemia

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

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

Berlin, Germany

† Study has passed its completion date and status has not been verified in more than two years.

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