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

Dyslipidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970215
• Other study ID #: TA-8995-03
• Secondary ID: 2012-005643-24
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2013
• Last updated: August 20, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark : Danish Medicines and Health AuthorityThe Netherlands : Healthcare Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• TA-8995

• Atorvastatin

• Rosuvastatin

• TA-8995 0mg (placebo)

• Placebo Statin

Locations

Country	Name	City	State
Denmark	H:S Amager Hospital	Copenhagen
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Herlev University Hospital	Herlev
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Regionshopitalet - Silkeborg	Silkeborg
Netherlands	EB FlevoResearch B.V	Almere
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

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Countries where clinical trial is conducted

Denmark,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No