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

NCT ID: NCT01970215

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

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

Group Type: PLACEBO_COMPARATOR

TA-8995 0mg (placebo)

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Group 2

TA-8995 1mg \& placebo statin

Group Type: EXPERIMENTAL

TA-8995

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Group 3

TA-8995 2.5mg \& placebo statin

Group Type: EXPERIMENTAL

TA-8995

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Group 4

TA-8995 5mg \& placebo statin

Group Type: EXPERIMENTAL

TA-8995

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Group 5

TA-8995 10mg \& placebo statin

Group Type: EXPERIMENTAL

TA-8995

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Group 6

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

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

TA-8995 0mg (placebo)

Intervention Type: DRUG

Group 7

TA-8995 10mg \& atorvastatin 20mg

Group Type: ACTIVE_COMPARATOR

TA-8995

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Group 8

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

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

TA-8995 0mg (placebo)

Intervention Type: DRUG

Group 9

TA-8995 10mg \& rosuvastatin 10mg

Group Type: ACTIVE_COMPARATOR

TA-8995

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Interventions

TA-8995

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

TA-8995 0mg (placebo)

Intervention Type: DRUG

Placebo Statin

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xention Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H:S Amager Hospital

Copenhagen, , Denmark

Sydvestjysk Sygehus

Esbjerg, , Denmark

Herlev University Hospital

Herlev, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Regionshopitalet - Silkeborg

Silkeborg, , Denmark

EB FlevoResearch B.V

Almere Stad, , Netherlands

Andromed Amsterdam

Amsterdam, , Netherlands

Andromed Leiden

Amsterdam, , Netherlands

Academic Medical Centre

Amsterdam-Zuidoost, , Netherlands

Andromed Breda B.V

Breda, , Netherlands

Andromed Eindhoven

Eindhoven, , Netherlands

Andromed Noord B.V

Groningen, , Netherlands

Andromed Zoetermeer

Leiderdorp, , Netherlands

Andromed Rotterdam BV

Rotterdam, , Netherlands

Albert Schweitzer Ziekenhuis

Sliedrecht, , Netherlands

Andromed Oost

Velp, , Netherlands

Praktijk Zwijndrecht

Zwijndrecht, , Netherlands

Countries

Denmark; Netherlands

References

Martin SS, Ditmarsch M, Simmons M, Alp N, Turner T, Davidson MH, Kastelein JJP. Comparison of low-density lipoprotein cholesterol equations in patients with dyslipidaemia receiving cholesterol ester transfer protein inhibition. Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):148-155. doi: 10.1093/ehjcvp/pvac056.

Reference Type: DERIVED

PMID: 36307922 (View on PubMed)

van Capelleveen JC, Kastelein JJ, Zwinderman AH, van Deventer SJ, Collins HL, Adelman SJ, Round P, Ford J, Rader DJ, Hovingh GK. Effects of the cholesteryl ester transfer protein inhibitor, TA-8995, on cholesterol efflux capacity and high-density lipoprotein particle subclasses. J Clin Lipidol. 2016 Sep-Oct;10(5):1137-1144.e3. doi: 10.1016/j.jacl.2016.06.006. Epub 2016 Jun 25.

Reference Type: DERIVED

PMID: 27678430 (View on PubMed)

Hovingh GK, Kastelein JJ, van Deventer SJ, Round P, Ford J, Saleheen D, Rader DJ, Brewer HB, Barter PJ. Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2015 Aug 1;386(9992):452-60. doi: 10.1016/S0140-6736(15)60158-1. Epub 2015 Jun 2.

Reference Type: DERIVED

PMID: 26047975 (View on PubMed)

Other Identifiers

2012-005643-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TA-8995-03

Identifier Type: -

Identifier Source: org_study_id