Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Genzyme Isis Pharmaceuticals |
---|---|
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00770146 |
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in subjects with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).
Condition | Intervention | Phase |
---|---|---|
Hypercholesterolemia Coronary Heart Disease |
Drug: Mipomersen sodium Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of ISIS 301012 (Mipomersen) As Add-on Therapy in High Risk Hypercholesterolemic Patients |
Estimated Enrollment: | 180 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
200 mg mipomersen
|
Drug: Mipomersen sodium
200 mg (1 mL), weekly subcutaneous injections for 26 weeks
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
1 mL placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to (QS) 1 mL with water for injection), weekly subcutaneous injections for 26 weeks
|
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL).
Elevated LDL is a major risk factor for coronary heart disease (CHD). Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B-100 (apoB-100). ApoB-100 plays a role in producing low density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDLC is an independent risk factor for the development of coronary heart disease (CHD) or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in subjects with high cholesterol who are at high risk for CHD and who are already on the maximally tolerated dose of statin.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Genzyme MedInfo | 800-745-4447 or 617-252-7832 | medinfo@genzyme.com, |
Study Chair: | Joanne M Donovan, M.D., Ph.D. | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | 301012-CS12 |
Study First Received: | October 8, 2008 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00770146 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis |
Coronary Disease Riboflavin Metabolic Disorder Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis |
Coronary Disease Cardiovascular Diseases Hypercholesterolemia Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |