DyslipidemiaPhase 2TULIPNCT01970215
TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
A Phase 2 study testing TA-8995, Atorvastatin and Rosuvastatin in people with Dyslipidemia, run by Xention Ltd at 17 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- TA-8995, Atorvastatin and Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Netherlands12 sites
EB FlevoResearch B.V
Almere Stad
Andromed Amsterdam
Amsterdam
Andromed Leiden
Amsterdam
Academic Medical Centre
Amsterdam-Zuidoost
Andromed Breda B.V
Breda
Andromed Eindhoven
Eindhoven
Andromed Noord B.V
Groningen
Andromed Zoetermeer
Leiderdorp
Andromed Rotterdam BV
Rotterdam
Albert Schweitzer Ziekenhuis
Sliedrecht
Andromed Oost
Velp
Praktijk Zwijndrecht
Zwijndrecht
Denmark5 sites
H:S Amager Hospital
Copenhagen
Sydvestjysk Sygehus
Esbjerg
Herlev University Hospital
Herlev
Hvidovre Hospital
Hvidovre
Regionshopitalet - Silkeborg
Silkeborg
About this study
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
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
- Being tested
- TA-8995, Atorvastatin, Rosuvastatin, TA-8995 0mg (placebo), Placebo Statin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-8995Drug
AtorvastatinDrug
RosuvastatinDrug
TA-8995 0mg (placebo)Drug
Placebo StatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | TA-8995 0mg (placebo) \& placebo statin Receives: Drug: TA-8995 0mg (placebo); Drug: Placebo Statin |
| Group 2 | Experimental | TA-8995 1mg \& placebo statin Receives: Drug: TA-8995; Drug: Placebo Statin |
| Group 3 | Experimental | TA-8995 2.5mg \& placebo statin Receives: Drug: TA-8995; Drug: Placebo Statin |
| Group 4 | Experimental | TA-8995 5mg \& placebo statin Receives: Drug: TA-8995; Drug: Placebo Statin |
| Group 5 | Experimental | TA-8995 10mg \& placebo statin Receives: Drug: TA-8995; Drug: Placebo Statin |
| Group 6 | Active comparator | TA-8995 0mg (placebo) \& atorvastatin 20mg Receives: Drug: Atorvastatin; Drug: TA-8995 0mg (placebo) |
| Group 7 | Active comparator | TA-8995 10mg \& atorvastatin 20mg Receives: Drug: TA-8995; Drug: Atorvastatin |
| Group 8 | Active comparator | TA-8995 0mg (placebo) \& rosuvastatin 10mg Receives: Drug: Rosuvastatin; Drug: TA-8995 0mg (placebo) |
| Group 9 | Active comparator | TA-8995 10mg \& rosuvastatin 10mg Receives: Drug: TA-8995; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xention Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970215
- Sponsor's protocol ID
- TA-8995-03
- Other IDs
- 2012-005643-24
- Acronym
- TULIP
- Status last verified
- Aug 2014
- First submitted
- 21 Oct 2013
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36307922van 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.
PubMed 27678430Hovingh 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.
PubMed 26047975
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01970215
- Acronym / sponsor ID
- TULIP / TA-8995-03
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Xention LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: TA-8995 0mg (placebo), Drug: Placebo StatinTA-8995 0mg (placebo) \& placebo statin |
| Group 2 | Experimental | Drug: TA-8995, Drug: Placebo StatinTA-8995 1mg \& placebo statin |
| Group 3 | Experimental | Drug: TA-8995, Drug: Placebo StatinTA-8995 2.5mg \& placebo statin |
| Group 4 | Experimental | Drug: TA-8995, Drug: Placebo StatinTA-8995 5mg \& placebo statin |
| Group 5 | Experimental | Drug: TA-8995, Drug: Placebo StatinTA-8995 10mg \& placebo statin |
| Group 6 | Active comparator | Drug: Atorvastatin, Drug: TA-8995 0mg (placebo)TA-8995 0mg (placebo) \& atorvastatin 20mg |
| Group 7 | Active comparator | Drug: TA-8995, Drug: AtorvastatinTA-8995 10mg \& atorvastatin 20mg |
| Group 8 | Active comparator | Drug: Rosuvastatin, Drug: TA-8995 0mg (placebo)TA-8995 0mg (placebo) \& rosuvastatin 10mg |
| Group 9 | Active comparator | Drug: TA-8995, Drug: RosuvastatinTA-8995 10mg \& rosuvastatin 10mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-8995 | Drug | Group 2, Group 3, Group 4, Group 5, Group 7, Group 9 |
| Atorvastatin | Drug | Group 6, Group 7 |
| Rosuvastatin | Drug | Group 8, Group 9 |
| TA-8995 0mg (placebo) | Drug | Group 1, Group 6, Group 8 |
| Placebo Statin | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Derived from this study: PubMed 36307922Martin 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.
- Derived from this study: PubMed 27678430van 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.
- Derived from this study: PubMed 26047975Hovingh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TA-8995, Atorvastatin and Rosuvastatin in people with Dyslipidemia, run by Xention Ltd at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Netherlands, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970215, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.