Mild dyslipidaemia MedDRA version: 17.0 Level: LLT Classification code 10020049 Term: High cholesterol System Organ Class: 100000004848
Conditions
Interventions
Product Code: TA-8995
Pharmaceutical Form: Capsule
INN or Proposed INN: TA-8995
Other descriptive name: TA-8995
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
P
Sponsors
Xention Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 2.5 mmol/L and 0.8 mmol/L, and TG levels =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of TA 8995, alone and in combination with statin therapy, on the elevation of HDL C and reduction of LDL C following 12 weeks of treatment.;Secondary Objective: The secondary objectives of this study are the following: 1. To evaluate the efficacy of TA 8995 alone and in combination with statins on HDL-C and LDL-C following 12 weeks of treatment. 2. To evaluate the safety and tolerability of TA 8995 in patients with mild dyslipidaemia as assessed by adverse events and changes from baseline in ECG, laboratory values (haematology, clinical chemistry parameters, and urinalysis), vital signs (blood pressure, pulse rate, and body temperature), and salivary cortisol, plasma aldosterone, high sensitivity C reactive protein (hsCRP) and endothelin 1 levels. ;Primary end point(s): The co-primary efficacy endpoints are the percentage changes in both HDL C and LDL C levels ;Timepoint(s) of evaluation of this end point: At Week 12 compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change in triglyceride (TG); • Percent change in total cholesterol (TC); • Percent change in apolipoprotein AI (ApoA1), apolipoprotein B (ApoB), apolipoprotein E (ApoE) and • Percent change in lipoprotein(a) (Lp[a]) ;Timepoint(s) of evaluation of this end point: Week 12 compared to baseline | — |
Countries
Denmark, Netherlands
Contacts
Public ContactRegulatory Submissions
Medpace UK
Outcome results
None listed