- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00694109
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
August 1, 2016 updated by: Kastle Therapeutics, LLC
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.
Study Overview
Status
Completed
Conditions
- Metabolic Diseases
- Congenital Abnormalities
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Dyslipidemias
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hypercholesterolemia
- Hyperlipidemias
- Hyperlipoproteinemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemia Type II
- Metabolic Disorder
- Hypercholesterolemia, Autosomal Dominant
Intervention / Treatment
Detailed Description
All familial hypercholesterolemia (FH) or severe hypercholesterolemia participants who had tolerated the treatment regimen in Protocol 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849) or MIPO3500108 (NCT00794664) and satisfactorily completed the study through to Week 28 were eligible for participation in this open label treatment extension study for up to 4 years or until mipomersen was commercially available, whichever comes first.
Consenting participants who had tolerated mipomersen and satisfactorily completed 301012-CS17 (NCT00477594) through Year 3 may also enroll for up to an additional 2 years of treatment in this study or until mipomersen was commercially available, whichever comes first.
All participants, who entered the study, received 200 mg mipomersen (ISIS 301012) subcutaneously (s.c.) every week, including those who were randomized to placebo in their initial study.
Participants who were originally enrolled in Protocol 301012-CS5 (NCT00607373) and weighed <50 kg received 160 mg every week.
Dose adjustments (70 mg injections administered three times per week, on separate days) were allowed for participants who were not tolerating or who had previous issues with tolerating the once a week injections due to injection site reactions (ISRs) or flu-like symptoms.
Study visits and clinical lab assessments including hematology with differential, chemistry, serum lipid panel (total cholesterol, LDL-C, very low density lipoprotein cholesterol (VLDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein B (apoB), apoA-1, triglycerides (TG) and Lp(a), and urinalysis was to be performed every 4-10 weeks during the treatment period.
Plasma trough mipomersen (ISIS 301012) levels was to be measured to estimate exposure.
Participants who completed dosing or who discontinued prematurely from the study for any reason was followed for safety for 24 weeks (safety follow-up period) after their last dose of mipomersen (ISIS 301012) or longer in the case of a significant adverse events (AE) or abnormal biochemical or clinical finding.
Participants were required to return to the study center for clinical evaluation and clinical laboratory tests every 8 weeks during the safety follow-up period.
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil
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Quebec, Canada, G1V 4M6
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M5
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Ontario
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London, Ontario, Canada, N6A 5K8
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H1T 1C8
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Montreal, Quebec, Canada, H2W 1R7
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Sherbrooke, Quebec, Canada, J1H 5N4
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Singapore, Singapore, 168752
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Observatory, South Africa, 7925
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Parktown, South Africa, 2193
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Taipei, Taiwan, 11217
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London, United Kingdom, WC1N 3BG
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California
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Mission Viejo, California, United States, 92691
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Newport Beach, California, United States, 92660
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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Florida
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Melbourne, Florida, United States, 32901
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Winter Park, Florida, United States, 32792
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Illinois
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Chicago, Illinois, United States, 60654
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Kansas
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Kansas City, Kansas, United States, 66160
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Maine
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Biddeford, Maine, United States, 04005
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Missouri
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St Louis, Missouri, United States, 63110
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New Hampshire
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Concord, New Hampshire, United States, 03301
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New York
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New York, New York, United States, 10032
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North Carolina
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Charlotte, North Carolina, United States, 28204
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Durham, North Carolina, United States, 27710
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Ohio
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Cincinnati, Ohio, United States, 45212
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Franklin, Ohio, United States, 45005
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Oregon
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Portland, Oregon, United States, 97239
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Dallas, Texas, United States, 75226
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Washington
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Seattle, Washington, United States, 98104
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Satisfactory completion of dosing in their initial study (Protocol 301012-CS5 [NCT00607373], 301012-CS7 [NCT00706849], 301012-CS17 [NCT00477594], or MIPO3500108 [NCT00794664])
Exclusion Criteria:
- Had any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mipomersen
Mipomersen Sodium once a week for up to 4 years (depending on participant's consent).
Participants were followed for additional 24 week post-treatment.
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Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Apolipoprotein B (Apo B)
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Total Cholesterol
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Triglycerides
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Lipoprotein (a)
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in LDL Particles' Size (Total)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in LDL Particles' Size (Large)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in LDL Particles' Size (Medium)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in LDL Particles' Size (Small)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in LDL Particles' Size (Very Small)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in HDL Particles' Size (Large)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in HDL Particles' Size (Medium)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in HDL Particles' Size (Small)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in VLDL Particles' Size (Medium)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in VLDL Particles' Size (Small)
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Change From Baseline in C-Reactive Protein
Time Frame: Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)
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Percent Change From Baseline in Apolipoprotein A-1
Time Frame: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).
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Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Duell PB, Santos RD, Kirwan BA, Witztum JL, Tsimikas S, Kastelein JJP. Long-term mipomersen treatment is associated with a reduction in cardiovascular events in patients with familial hypercholesterolemia. J Clin Lipidol. 2016 Jul-Aug;10(4):1011-1021. doi: 10.1016/j.jacl.2016.04.013. Epub 2016 May 9.
- Santos RD, Duell PB, East C, Guyton JR, Moriarty PM, Chin W, Mittleman RS. Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension. Eur Heart J. 2015 Mar 1;36(9):566-75. doi: 10.1093/eurheartj/eht549. Epub 2013 Dec 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
June 5, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (Estimate)
June 10, 2008
Study Record Updates
Last Update Posted (Estimate)
September 9, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- Dyslipidemias
- Congenital Abnormalities
- Hypercholesterolemia
- Hyperlipidemias
- Metabolism, Inborn Errors
- Metabolic Diseases
- Hyperlipoproteinemia Type II
- Lipid Metabolism Disorders
- Genetic Diseases, Inborn
- Infant, Newborn, Diseases
- Hyperlipoproteinemias
- Lipid Metabolism, Inborn Errors
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Mipomersen
Other Study ID Numbers
- 301012-CS6
- 2005-003450-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.CompletedMetabolic Diseases | Congenital Abnormalities | Infant, Newborn, Diseases | Genetic Diseases, Inborn | Dyslipidemias | Metabolism, Inborn Errors | Lipid Metabolism Disorders | Hypercholesterolemia | Hyperlipidemias | Hyperlipoproteinemias | Lipid Metabolism, Inborn Errors | Hyperlipoproteinemia Type II | Metabolic... and other conditionsUnited States
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Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.CompletedCoronary Artery Disease | Heterozygous Familial HypercholesterolemiaUnited States, Canada
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Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.CompletedHypercholesterolemia | Coronary Heart DiseaseUnited States
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Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Completed