Hypercholesterolemia Clinical Trial
— ASSISTOfficial title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of ISIS 301012 Administration in High Risk Statin Intolerant Subjects
Verified date | March 2015 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Ministry of Health, Welfare and Sport |
Study type | Interventional |
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects intolerant to statins.
Status | Completed |
Enrollment | 34 |
Est. completion date | January 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of statin intolerance - Diagnosis of Coronary Artery Disease (CAD) - Diagnosis of hypercholesterolemia - Stable weight for > 6 weeks Exclusion Criteria: - Significant health problems in the recent past (=24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Genzyme, a Sanofi Company | Ionis Pharmaceuticals, Inc. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point | Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Triglycerides at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point | Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point | Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point | The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point | Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point | High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Other | High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point | LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides =400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Primary | Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Primary | Summary of Participants With Adverse Events | The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date. Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Severity was assessed as: Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable; Moderate-symptom makes the patient uncomfortable, affects performance of daily activities; Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. |
Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52) | Yes |
Secondary | Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point | Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Secondary | Apolipoprotein B at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Secondary | Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point | Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Secondary | Total Cholesterol at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point | Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
Secondary | Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point | The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment. | Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose). | No |
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