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

Xention

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Placebo Statin; Drug: TA-8995 0mg (placebo); Drug: TA-8995; Drug: Atorvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970215

TA-8995-03

2012-005643-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 364 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 9 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

TA-8995 0mg (placebo) \& placebo statin

Treatment:

Drug: Placebo Statin

Drug: TA-8995 0mg (placebo)

Group 2

Experimental group

Description:

TA-8995 1mg \& placebo statin

Treatment:

Drug: Placebo Statin

Drug: TA-8995

Group 3

Experimental group

Description:

TA-8995 2.5mg \& placebo statin

Treatment:

Drug: Placebo Statin

Drug: TA-8995

Group 4

Experimental group

Description:

TA-8995 5mg \& placebo statin

Treatment:

Drug: Placebo Statin

Drug: TA-8995

Group 5

Experimental group

Description:

TA-8995 10mg \& placebo statin

Treatment:

Drug: Placebo Statin

Drug: TA-8995

Group 6

Active Comparator group

Description:

TA-8995 0mg (placebo) \& atorvastatin 20mg

Treatment:

Drug: TA-8995 0mg (placebo)

Drug: Atorvastatin

Group 7

Active Comparator group

Description:

TA-8995 10mg \& atorvastatin 20mg

Treatment:

Drug: Atorvastatin

Drug: TA-8995

Group 8

Active Comparator group

Description:

TA-8995 0mg (placebo) \& rosuvastatin 10mg

Treatment:

Drug: Rosuvastatin

Drug: TA-8995 0mg (placebo)

Group 9

Active Comparator group

Description:

TA-8995 10mg \& rosuvastatin 10mg

Treatment:

Drug: Rosuvastatin

Drug: TA-8995