TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)

Launched by XENTION LTD · Oct 25, 2013

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Eligibility criteria

• Inclusion Criteria:
• • Fasting LDL-C levels \>2.5 mmol/L and \<4.5 mmol/L, HDL-C levels \<1.8 mmol/L and \>0.8 mmol/L, and TG levels \<4.5 mmol/L after run in or washout of existing therapies
• • Not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening
• Exclusion Criteria:
• • Body mass index \>32 kg/m2;
• • Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
• • Any clinical manifestation of atherosclerotic vascular disease;
• • Diagnosis of type 1 diabetes;
• • Uncontrolled type 2 diabetes: haemoglobin A1c \>8%;
• • Uncontrolled hypertension: sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>90 mmHg;
• • History of hyperaldosteronism;
• • Active muscle disease or persistent creatine kinase concentration \>3 × the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result;