TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
- Conditions
- Dyslipidemia
- Interventions
- Registration Number
- NCT01970215
- Lead Sponsor
- Xention Ltd
- Brief Summary
The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy.
The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 364
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 Placebo Statin TA-8995 2.5mg \& placebo statin Group 5 TA-8995 TA-8995 10mg \& placebo statin Group 4 Placebo Statin TA-8995 5mg \& placebo statin Group 1 Placebo Statin TA-8995 0mg (placebo) \& placebo statin Group 1 TA-8995 0mg (placebo) TA-8995 0mg (placebo) \& placebo statin Group 2 Placebo Statin TA-8995 1mg \& placebo statin Group 2 TA-8995 TA-8995 1mg \& placebo statin Group 9 TA-8995 TA-8995 10mg \& rosuvastatin 10mg Group 9 Rosuvastatin TA-8995 10mg \& rosuvastatin 10mg Group 6 TA-8995 0mg (placebo) TA-8995 0mg (placebo) \& atorvastatin 20mg Group 7 TA-8995 TA-8995 10mg \& atorvastatin 20mg Group 5 Placebo Statin TA-8995 10mg \& placebo statin Group 8 TA-8995 0mg (placebo) TA-8995 0mg (placebo) \& rosuvastatin 10mg Group 3 TA-8995 TA-8995 2.5mg \& placebo statin Group 4 TA-8995 TA-8995 5mg \& placebo statin Group 6 Atorvastatin TA-8995 0mg (placebo) \& atorvastatin 20mg Group 7 Atorvastatin TA-8995 10mg \& atorvastatin 20mg Group 8 Rosuvastatin TA-8995 0mg (placebo) \& rosuvastatin 10mg
- Primary Outcome Measures
Name Time Method The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline. 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Albert Schweitzer Ziekenhuis
🇳🇱Sliedrecht, Netherlands
Andromed Zoetermeer
🇳🇱Leiderdorp, Netherlands
Andromed Breda B.V
🇳🇱Breda, Netherlands
Andromed Rotterdam BV
🇳🇱Rotterdam, Netherlands
Sydvestjysk Sygehus
🇩🇰Esbjerg, Denmark
H:S Amager Hospital
🇩🇰Copenhagen, Denmark
Herlev University Hospital
🇩🇰Herlev, Denmark
EB FlevoResearch B.V
🇳🇱Almere, Netherlands
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Andromed Leiden
🇳🇱Amsterdam, Netherlands
Regionshopitalet - Silkeborg
🇩🇰Silkeborg, Denmark
Andromed Amsterdam
🇳🇱Amsterdam, Netherlands
Academic Medical Centre
🇳🇱Amsterdam-Zuidoost, Netherlands
Andromed Eindhoven
🇳🇱Eindhoven, Netherlands
Andromed Noord B.V
🇳🇱Groningen, Netherlands
Praktijk Zwijndrecht
🇳🇱Zwijndrecht, Netherlands
Andromed Oost
🇳🇱Velp, Netherlands