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

August 20, 2014 updated by: Xention Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • H:S Amager Hospital
      • Esbjerg, Denmark
        • Sydvestjysk Sygehus
      • Herlev, Denmark
        • Herlev University Hospital
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • Silkeborg, Denmark
        • Regionshopitalet - Silkeborg
  • Netherlands
      • Almere, Netherlands
        • EB FlevoResearch B.V
      • Amsterdam, Netherlands
        • Andromed Amsterdam
      • Amsterdam, Netherlands
        • Andromed Leiden
      • Amsterdam-Zuidoost, Netherlands
        • Academic Medical Centre
      • Breda, Netherlands
        • Andromed Breda B.V
      • Eindhoven, Netherlands
        • Andromed Eindhoven
      • Groningen, Netherlands
        • Andromed Noord B.V
      • Leiderdorp, Netherlands
        • Andromed Zoetermeer
      • Rotterdam, Netherlands
        • Andromed Rotterdam BV
      • Sliedrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Velp, Netherlands
        • Andromed Oost
      • Zwijndrecht, Netherlands
        • Praktijk Zwijndrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
TA-8995 0mg (placebo) & placebo statin
Drug: TA-8995 0mg (placebo)
Drug: Placebo Statin
Experimental: Group 2
TA-8995 1mg & placebo statin
Drug: TA-8995
Drug: Placebo Statin
Experimental: Group 3
TA-8995 2.5mg & placebo statin
Drug: TA-8995
Drug: Placebo Statin
Experimental: Group 4
TA-8995 5mg & placebo statin
Drug: TA-8995
Drug: Placebo Statin
Experimental: Group 5
TA-8995 10mg & placebo statin
Drug: TA-8995
Drug: Placebo Statin
Active Comparator: Group 6
TA-8995 0mg (placebo) & atorvastatin 20mg
Drug: Atorvastatin
Drug: TA-8995 0mg (placebo)
Active Comparator: Group 7
TA-8995 10mg & atorvastatin 20mg
Drug: Atorvastatin
Drug: TA-8995
Active Comparator: Group 8
TA-8995 0mg (placebo) & rosuvastatin 10mg
Drug: Rosuvastatin
Drug: TA-8995 0mg (placebo)
Active Comparator: Group 9
TA-8995 10mg & rosuvastatin 10mg
Drug: Rosuvastatin
Drug: TA-8995

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xention Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-8995-03
  • 2012-005643-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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