Safety and Efficacy of ISIS 301012 (Mipomersen) As Add-on Therapy in High Risk Hypercholesterolemic Patients - Full Text View

Sponsor:	Genzyme
Collaborator:	Isis Pharmaceuticals
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00770146

Purpose

The purpose of this study is to evaluate the safety and efficacy of dosing with ISIS 301012 (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: ISIS 301012 (mipomersen sodium) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases

Drug Information available for: Mipomersen sodium

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Percent change in low-density lipoprotein cholesterol (LDL-C) from Baseline to Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change in apolipoprotein B (apoB), from Baseline to Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Percent change in total cholesterol from Baseline to week 28 [ Time Frame: week 28 ] [ Designated as safety issue: No ]
Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from Baseline to Week 28 [ Time Frame: week 28 ] [ Designated as safety issue: No ]
Percent change in triglycerides from Baseline to Week 28 [ Time Frame: week 28 ] [ Designated as safety issue: No ]
Percent change in HDL-C from Baseline to Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Percent change in Lipoprotein (a)(Lp(a)) from Baseline to Week 28 [ Time Frame: Week 28 ] [ Designated as safety issue: No ]

Enrollment:	158
Study Start Date:	November 2008
Study Completion Date:	October 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 200 mg ISIS 301012 (mipomersen)	Drug: ISIS 301012 (mipomersen sodium) 200 mg (1 mL), weekly subcutaneous injections for 26 weeks Other Name: ISIS 301012
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

Detailed Description:

Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL).

Elevated LDL is a major risk factor for coronary heart disease (CHD). ISIS 301012 (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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of hypercholesterolemia (LDL-C ≥ 100 mg/dL)
At high risk of coronary heart disease (CHD)
On stable, maximally tolerated statin therapy for 8 weeks
On stable, low fat diet for 12 weeks
Stable weight for 6 weeks

Exclusion Criteria:

Significant health problems in the recent past including heart attack
Stroke
Coronary syndrome
Unstable angina
Heart failure
Significant arrhythmia
Hypertension
Blood disorders
Liver disease
Cancer
Digestive disorders
Type I diabetes, or uncontrolled Type II diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770146

Show 62 Study Locations

Sponsors and Collaborators

Genzyme

Isis Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00770146 History of Changes
Other Study ID Numbers:	301012CS12
Study First Received:	October 8, 2008
Last Updated:	December 29, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis

Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 09, 2012