A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels

Kowa Research Europe0 sites350 target enrollmentDecember 17, 2013

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Kowa Research Europe

•1\. Able to understand and comply with study procedures and give written informed consent
•2\. Aged \=18 years
•3\. Have no clinically significant abnormal findings on medical history, physical examination, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine that would impair participation or safety in the trial or clinically relevant abnormal findings that in the opinion of the investigator could interfere with the objectives of the study or the safety of the patient
•4\. After treatment with stable statin therapy for at least 12 weeks prior to screening, have a screening LDL C of no more than 10 mg/dL above the NCEP ATP III target (see Note 2 below):
•LDL C \<70 or \<100 mg/dL for patients with CHD or CHD equivalent
•LDL C \<130 mg/dL for patients with multiple risk factors
•LDL C \<160 mg/dL for patients with 0\-1 risk factor
•Note 1: Any statin approved by the regulatory authority in the respective country is allowed, with the exception of pravastatin, lovastatin, and fluvastatin
•Note 2: If LDL\-C is greater than 10 mg/dL (0\.259 mmol/L) above target, patients are only eligible for the study if they are on the maximum allowable statin dose as per approved SPC in the respective country or on the maximum dose tolerated by the respective patient.
•5\. Fasting TG value at screening is \=175 mg/dL and \=500 mg/dL

•1\. Patients who require other lipid lowering treatments in addition to study drug (K 877\) and statin
•2\. Patients with body mass index \=40 kg/m2
•3\. Patients with homozygous familial hypercholesterolaemia (heterozygous is permitted) or familial hypoalphalipoproteinaemia
•4\. Patients with type 1 diabetes mellitus
•5\. Patients with poorly controlled type 2 diabetes mellitus (haemoglobin A1c \[HbA1c] \>10%)
•6\. Patients who are receiving insulin or insulin analog treatment except for stable basal insulin therapy with a single insulin
•7\. Patients with moderate or severe renal impairment (ie, estimated glomerular filtration rate \<50 mL/min/1\.73m2\) at screening
•8\. Patients with serious liver dysfunction; liver function test values \>3 × upper limit of the normal (ULN) of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at any screening visit
•9\. Patients with a creatine kinase (CK) level \>3 × ULN at screening
•10\. Patients with hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormalities, eg, persistent increase in serum transaminase), gall bladder disease, or pancreatitis