Clinical trial NCT00216463 (phase 2, status: completed)
Conditions: hypercholesterolemia
ICD codes: E78.01, E78.00, Z83.42
Drugs: isis 301012 or placebo, isis 301012 or placebo, isis 301012 or placebo, isis 301012 or placebo, isis 301012 or placebo
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Eligibility criteria:

        Inclusion Criteria:

          -  BMI >/= 25 to </= 32 kg/m^2

          -  fasting stable LDL-cholesterol >/= 130 mg/dL (3.36 mmol/L) and triglycerides < 400
             mg/dL (4.55 mmol/L)

          -  Females not of childbearing potential

        Exclusion Criteria:

          -  No endocrine, hematologic, renal, hepatic, metabolic, psychiatric, neurology,
             pulmonary or cardiovascular disease

          -  Subjects who test positive for hepatitis B, C or HIV

          -  Current diagnosis or known history of liver disease, such as acute or chronic
             hepatitis, liver cirrhosis, liver steatosis, or liver function abnormalities such as
             AST, ALT, GGT, or total bilirubin >/= 1.5 x ULN at Screening

          -  A systolic blood pressure >/= 160 mmHg or a diastolic blood pressure >/= 95 mmHg on 2
             occasions during Screening

          -  Concomitant medications within 14 days of dosing, except hormone replacement therapy
             for post-menopausal women and acetylsalicylic acid or paracetamol dosed for fewer than
             five consecutive days

          -  Subject has taken any lipid-lowering drug within 30 days or five half-lives (of the
             lipid-lowering drug) whichever is longer, prior to Screening

          -  Alcohol or drug abuse within 2 years of Screening

          -  Donated blood (450 mL) within the 3 months prior to Screening or suffered significant
             blood loss equal to a blood donor portion

          -  Subject smokes > 10 cigarettes, or more than one pipe or one cigar per day