Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00776321
• Date of registration: 17/10/2008
• Prospective Registration: No
• Primary sponsor: Karo Bio AB
• Public title: Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
• Scientific title: A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
• Date of first enrolment: September 2006
• Target sample size: 142
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00776321
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- clinical diagnosis of hypercholesterolemia



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Hypercholesterolemia

Intervention(s)

Drug: Placebo

Drug: Eprotirome

Primary Outcome(s)

LDL cholesterol [Time Frame: Week 12]

Secondary Outcome(s)

Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes [Time Frame: 12 week]

Secondary ID(s)

EudraCT No: 2006-003191-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors