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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TA-8995
Atorvastatin
Rosuvastatin
TA-8995 0mg (placebo)
Placebo Statin
Sponsored by
Xention Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • H:S Amager Hospital
  • Sydvestjysk Sygehus
  • Herlev University Hospital
  • Hvidovre Hospital
  • Regionshopitalet - Silkeborg
  • EB FlevoResearch B.V
  • Academic Medical Centre
  • Andromed Amsterdam
  • Andromed Leiden
  • Andromed Breda B.V
  • Andromed Eindhoven
  • Andromed Noord B.V
  • Andromed Zoetermeer
  • Andromed Rotterdam BV
  • Albert Schweitzer Ziekenhuis
  • Andromed Oost
  • Praktijk Zwijndrecht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Group 7

Group 8

Group 9

Arm Description

TA-8995 0mg (placebo) & placebo statin

TA-8995 1mg & placebo statin

TA-8995 2.5mg & placebo statin

TA-8995 5mg & placebo statin

TA-8995 10mg & placebo statin

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

TA-8995 10mg & atorvastatin 20mg

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

TA-8995 10mg & rosuvastatin 10mg

Outcomes

Primary Outcome Measures

The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2013
Last Updated
August 20, 2014
Sponsor
Xention Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01970215
Brief Title
TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
Acronym
TULIP
Official Title
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of TA-8995 in Patients With Mild Dyslipidaemia, Alone and In Combination With Statin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xention Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
TA-8995 0mg (placebo) & placebo statin
Arm Title
Group 2
Arm Type
Experimental
Arm Description
TA-8995 1mg & placebo statin
Arm Title
Group 3
Arm Type
Experimental
Arm Description
TA-8995 2.5mg & placebo statin
Arm Title
Group 4
Arm Type
Experimental
Arm Description
TA-8995 5mg & placebo statin
Arm Title
Group 5
Arm Type
Experimental
Arm Description
TA-8995 10mg & placebo statin
Arm Title
Group 6
Arm Type
Active Comparator
Arm Description
TA-8995 0mg (placebo) & atorvastatin 20mg
Arm Title
Group 7
Arm Type
Active Comparator
Arm Description
TA-8995 10mg & atorvastatin 20mg
Arm Title
Group 8
Arm Type
Active Comparator
Arm Description
TA-8995 0mg (placebo) & rosuvastatin 10mg
Arm Title
Group 9
Arm Type
Active Comparator
Arm Description
TA-8995 10mg & rosuvastatin 10mg
Intervention Type
Drug
Intervention Name(s)
TA-8995
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
TA-8995 0mg (placebo)
Intervention Type
Drug
Intervention Name(s)
Placebo Statin
Primary Outcome Measure Information:
Title
The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
H:S Amager Hospital
City
Copenhagen
Country
Denmark
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
Country
Denmark
Facility Name
Herlev University Hospital
City
Herlev
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
Regionshopitalet - Silkeborg
City
Silkeborg
Country
Denmark
Facility Name
EB FlevoResearch B.V
City
Almere
Country
Netherlands
Facility Name
Academic Medical Centre
City
Amsterdam-Zuidoost
Country
Netherlands
Facility Name
Andromed Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Andromed Leiden
City
Amsterdam
Country
Netherlands
Facility Name
Andromed Breda B.V
City
Breda
Country
Netherlands
Facility Name
Andromed Eindhoven
City
Eindhoven
Country
Netherlands
Facility Name
Andromed Noord B.V
City
Groningen
Country
Netherlands
Facility Name
Andromed Zoetermeer
City
Leiderdorp
Country
Netherlands
Facility Name
Andromed Rotterdam BV
City
Rotterdam
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Sliedrecht
Country
Netherlands
Facility Name
Andromed Oost
City
Velp
Country
Netherlands
Facility Name
Praktijk Zwijndrecht
City
Zwijndrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27678430
Citation
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.
Results Reference
derived
PubMed Identifier
26047975
Citation
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.
Results Reference
derived

Learn more about this trial

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

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