A clinical trial to study the efficacy and safety of eprotirome in Familial Hypercholesterolaemia patients who are currently treated with standard medicatio
Phase 3
- Conditions
- Health Condition 1: null- Heterozygous Familial Hypercholesterolemia
- Registration Number
- CTRI/2012/02/002413
- Lead Sponsor
- Karo Bio AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 630
Inclusion Criteria
•Patients with confirmed HeFH and 18 years of age at screening
•Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
•Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
•On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation
Exclusion Criteria
•Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method