Effects of TA 8995 given orally in patients with mild dyslipidaemia alone or in combination with atorvastatin and rostuvastati

• Conditions: Mild dyslipidaemia; MedDRA version: 14.1Level: LLTClassification code 10020049Term: High cholesterolSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-005643-24-DK
• Lead Sponsor: Xention Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 995

Inclusion Criteria

Patients meeting the following criteria will be eligible to participate in the study:
1.Understanding of the study procedures, willing to adhere to the study schedules and diet, and agreement to participate in the study by giving written informed consent prior to screening (Visit 1);
2.Men or women 18 to 75 years of age, inclusive;
•Women may be enrolled if all 3 of the following criteria are met:
?They are not pregnant,
?They are not breastfeeding, and
?They do not plan on becoming pregnant during the study;
•Women of childbearing potential must have a negative urine pregnancy test at screening (Visit 1). Note: Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the Investigator:
?They have had a hysterectomy or tubal ligation at minimum 1 cycle prior to signing the ICF or
?They are post-menopausal, defined as >1 year since their last menstrual period for women >55 years of age or 1 year since their last menstrual period and have an FSH level in menopausal range for women <55 years of age;
•Women of childbearing potential must agree to use an effective method of avoiding pregnancy from screening to 90 days after the last visit. Men whose partners are of childbearing potential must agree to use an effective method of avoiding pregnancy from screening to 90 days after the last visit. Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices,
3.Not on lipid altering therapy at screening or on lipid altering treatment regimens at screening; patients currently taking lipid altering medications must be able to safely discontinue all lipid altering therapy during the run in/washout period;
4.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.; and
5.Willingness to maintain stable diet and physical activity level throughout the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 865
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

1.Body mass index >32 kg/m2;
2.Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
3.Any clinical manifestation of atherosclerotic vascular disease;
4.Diagnosis of type 1 diabetes;
5.Uncontrolled type 2 diabetes: haemoglobin A1c = 8%;
6.Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >90 mmHg;
7.History of hyperaldosteronism;
8.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;
9.Corrected QT interval >450 ms;
10.History of Torsades de Pointes or other clinically significant arrhythmia;
11.Clinically significant renal dysfunction: serum creatinine >1.5 X ULN;
12.Clinically significant hepatic dysfunction: gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >2 X ULN, or bilirubin >1.5 X ULN;
13.Anaemia, defined as haemoglobin concentration <11 g/dL for males and haemoglobin concentration <9 g/dL for females;
14.History of malignancy within the past 5 years, unless non invasive and in remission (disease free for >5 years) and written approval has been obtained from Sponsor, with the exception of skin cancers not including malignant melanoma;
15.Evidence of any other clinically significant non cardiac disease or condition that, in the opinion of the Investigator, would preclude the patient’s participation in the study;
16.History (within previous 1 year of consent) of alcohol or substance dependence or abuse (except nicotine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV TR) criteria (see Appendix B);
17.Heavy smoking (>20 cigarettes/day);
18.Known statin or CETP inhibitor intolerance;
19.Known allergy to any of the drugs administered in the study; or
20.Unable or unwilling to cooperate with study procedures or TLC diet.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified