HIVPhase 4NILACHNCT01683656
ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART
A Phase 4 study testing niacin/laropiprant in people with HIV and Atherosclerosis, run by Calmy Alexandra at 7 sites in Switzerland.
Trial summary
HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV, Atherosclerosis
- What is being tested?
- niacin/laropiprant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 7 sitesSwitzerland
- Study dates
- Aug 2012to Jul 2014
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 40 years;
- Women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial.
- Signing the study consent form;
- Stable cART since at least 3 months (ie no recent drug change);
- HIV-RNA below 100 copies for at least 6 months;
- HDL-cholesterol <1.29 mmol/l for men; <1.42 mmol/l for women
Who cannot join
- Pregnancy or lactation;
- Congestive Heart Failure;
- Malignant Hypertension;
- Acute or chronic coronary artery diseases;
- Any known cardiac arrhythmias;
- Diabetes;
Show all 16Show fewer
- Concomitant cancer, rheumatologic disease or inflammatory bowel diseases;
- Concomitant renal or hepatic disease:
- Creatinine above 150 micromol/L
- Transaminases above 5 times upper normal limit
- Prothrombin time (Quick) value below 50%;
- Prior intolerance to niacin therapy (reported in a medical report);
- Cyclosporine, anti-inflammatory drugs (other than aspirin) or cytokine therapy in concomitant intake;
- Abnormal thyroid function;
- Excessive consumption of alcohol;
- Known severe lactose intolerance.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
University Hospital Basel
Basel, Canton of Basel-City, 4031
University Hospital Berne Inselspital
Bern, Canton of Bern, 3010
University Hospitals Genève
Geneva, Canton of Geneva, 1211
CHUV Cantonal University Hospital Vaud
Lausanne, Canton of Vaud, 1011
EOC Ente Ospedaliero Cantonale, civico
Lugano, Canton Ticino, 6903
Kantonsspital St Gallen
Sankt Gallen, Canton of St. Gallen, 9007
University Hospital Zurich
Zurich, Canton of Zurich
About this study
HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation.
The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation associated with HIV itself in HIV-individuals on cART.
Read more
NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT) in 90 subjects.
- Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions)
- Regimen 2: ER niacin/laropiprant placebo p.m.
The primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.
The proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in HIV patients. In addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.
- Conditions
- HIV, Atherosclerosis
- Being tested
- niacin/laropiprant, Placebo
- Keywords
- HIV, Atherosclerosis, Niacin/laropiprant, HDL
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niacin/laropiprantDrug
Also called Tredaptive
PlaceboDrug
Procedures for the manufacturing and testing of the placebo are compiled in the IMP/study drug dossier and comply with local regulatory requirements (by GMP certified manufacturer).
| Study group | Role | What they receive |
|---|---|---|
| ER Niacin/laropipant | Active comparator | ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study. Receives: Drug: niacin/laropiprant |
| ER Niacin/laropipant Placebo | Placebo comparator | ER niacin/laropiprant placebo p.m. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mean common carotid intima-media thickness
mean of maximal IMT value will be calculated over three cardiac cycles and for left and right carotid artery at baseline and week 48. The primary endpoint will be assessed by a single investigator in a blinded and anonymized fashion at cIMT Core Facility, Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada Responsible: Pr Jean-Claude Tardif.
Measured: 48 weeks
Secondary outcomes (4)
Mean hs-CRP plasma concentration changes
Measured: 12, 24, 48 weeks
Mean Total Cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, apolipoprotein, triglycerides, and apolipoprotein (apo) Al, B and E levels
Measured: 12, 24, 48 weeks
Mean biomarkers of inflammatory process (fibrinogen, S-VCAM-1, adiponectin, CCL2, CCL3, d-dimer, IL-6, TNF-alpha, Lp-PLA2) changes
Measured: 12, 24, 48 weeks
Clinical MACE: cardiovascular mortality, stroke, acute coronary syndromes, any cardiac arrhythmias, hospitalisation for cardiovascular causes, peripheral artery disease, revascularization.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Withdrawal of IMP from the market. Data on risk-benefit ratio pending.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calmy Alexandra
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Swiss National Science Foundation, Fondation Ernest Boninchi, Swiss Heart Foundation
- Responsible party
- Sponsor-investigator, Calmy Alexandra, University Hospital, Geneva
- Investigators
- Alexandra Calmy, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683656
- Sponsor's protocol ID
- NILACH 2012DR4097
- Acronym
- NILACH
- Status last verified
- Oct 2019
- First submitted
- 31 Aug 2012
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
PubMed 15843671Stemme S, Hansson GK. Immune mechanisms in atherogenesis. Ann Med. 1994 Jun;26(3):141-6. doi: 10.3109/07853899409147881.
PubMed 8074832Ledergerber B, Egger M, Opravil M, Telenti A, Hirschel B, Battegay M, Vernazza P, Sudre P, Flepp M, Furrer H, Francioli P, Weber R. Clinical progression and virological failure on highly active antiretroviral therapy in HIV-1 patients: a prospective cohort study. Swiss HIV Cohort Study. Lancet. 1999 Mar 13;353(9156):863-8. doi: 10.1016/s0140-6736(99)01122-8.
PubMed 10093977Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16.
PubMed 16878047Bonnet F, Chene G, Thiebaut R, Dupon M, Lawson-Ayayi S, Pellegrin JL, Dabis F, Morlat P; Groupe d'Epidemiologie Clinique du SIDA en Aquitaine (GECSA). Trends and determinants of severe morbidity in HIV-infected patients: the ANRS CO3 Aquitaine Cohort, 2000-2004. HIV Med. 2007 Nov;8(8):547-54. doi: 10.1111/j.1468-1293.2007.00508.x.
PubMed 17944688Sterne JA, May M, Bucher HC, Ledergerber B, Furrer H, Cavassini M, Bernasconi E, Hirschel B, Egger M; Swiss HIV Cohort. HAART and the heart: changes in coronary risk factors and implications for coronary risk in men starting antiretroviral therapy. J Intern Med. 2007 Mar;261(3):255-67. doi: 10.1111/j.1365-2796.2006.01761.x.
PubMed 17305648Calmy A, Gayet-Ageron A, Montecucco F, Nguyen A, Mach F, Burger F, Ubolyam S, Carr A, Ruxungtham K, Hirschel B, Ananworanich J; STACCATO Study Group. HIV increases markers of cardiovascular risk: results from a randomized, treatment interruption trial. AIDS. 2009 May 15;23(8):929-39. doi: 10.1097/qad.0b013e32832995fa.
PubMed 19425222Baker J, Ayenew W, Quick H, Hullsiek KH, Tracy R, Henry K, Duprez D, Neaton JD. High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection. J Infect Dis. 2010 Jan 15;201(2):285-92. doi: 10.1086/649560.
PubMed 19954384Montecucco F, Mach F. Update on statin-mediated anti-inflammatory activities in atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):127-42. doi: 10.1007/s00281-009-0150-y. Epub 2009 May 5.
PubMed 19415282Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998 May 12;97(18):1837-47. doi: 10.1161/01.cir.97.18.1837.
PubMed 9603539Gotto AM Jr. High-density lipoprotein cholesterol and triglycerides as therapeutic targets for preventing and treating coronary artery disease. Am Heart J. 2002 Dec;144(6 Suppl):S33-42. doi: 10.1067/mhj.2002.130301.
PubMed 12486414Thoenes M, Oguchi A, Nagamia S, Vaccari CS, Hammoud R, Umpierrez GE, Khan BV. The effects of extended-release niacin on carotid intimal media thickness, endothelial function and inflammatory markers in patients with the metabolic syndrome. Int J Clin Pract. 2007 Nov;61(11):1942-8. doi: 10.1111/j.1742-1241.2007.01597.x.
PubMed 17935553Paolini JF, Bays HE, Ballantyne CM, Davidson M, Pasternak R, Maccubbin D, Norquist JM, Lai E, Waters MG, Kuznetsova O, Sisk CM, Mitchel YB. Extended-release niacin/laropiprant: reducing niacin-induced flushing to better realize the benefit of niacin in improving cardiovascular risk factors. Cardiol Clin. 2008 Nov;26(4):547-60. doi: 10.1016/j.ccl.2008.06.007.
PubMed 19031552Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.
PubMed 19602880Dube MP, Wu JW, Aberg JA, Deeg MA, Alston-Smith BL, McGovern ME, Lee D, Shriver SL, Martinez AI, Greenwald M, Stein JH; AIDS Clinical Trials Group A5148 Study Team. Safety and efficacy of extended-release niacin for the treatment of dyslipidaemia in patients with HIV infection: AIDS Clinical Trials Group Study A5148. Antivir Ther. 2006;11(8):1081-9.
PubMed 17302378
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART
- ClinicalTrials.gov ID
- NCT01683656
- Acronym / sponsor ID
- NILACH / NILACH 2012DR4097
- Conditions
- HIV, Atherosclerosis
- Keywords
- HIV, Atherosclerosis, Niacin/laropiprant, HDL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawal of IMP from the market. Data on risk-benefit ratio pending.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Calmy AlexandraUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Swiss National Science Foundation, Fondation Ernest Boninchi, Swiss Heart Foundation
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Sep 2012 (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.
HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation.
The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation associated with HIV itself in HIV-individuals on cART.
NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT) in 90 subjects.
- Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions)
- Regimen 2: ER niacin/laropiprant placebo p.m.
The primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.
The proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in HIV patients. In addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ER Niacin/laropipant | Active comparator | Drug: niacin/laropiprantER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study. |
| ER Niacin/laropipant Placebo | Placebo comparator | Drug: PlaceboER niacin/laropiprant placebo p.m. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients > 40 years;
- Women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial.
- Signing the study consent form;
- Stable cART since at least 3 months (ie no recent drug change);
- HIV-RNA below 100 copies for at least 6 months;
Key exclusion criteria (16 listed)
- Pregnancy or lactation;
- Congestive Heart Failure;
- Malignant Hypertension;
- Acute or chronic coronary artery diseases;
- Any known cardiac arrhythmias;
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 |
|---|---|---|
| niacin/laropiprantAlso: Tredaptive | Drug | ER Niacin/laropipant |
| PlaceboProcedures for the manufacturing and testing of the placebo are compiled in the IMP/study drug dossier and comply with local regulatory requirements (by GMP certified manufacturer). | Drug | ER Niacin/laropipant Placebo |
Primary outcome
change in mean common carotid intima-media thickness
Time frame: 48 weeks
mean of maximal IMT value will be calculated over three cardiac cycles and for left and right carotid artery at baseline and week 48. The primary endpoint will be assessed by a single investigator in a blinded and anonymized fashion at cIMT Core Facility, Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada Responsible: Pr Jean-Claude Tardif.
4 secondary outcomes
Mean hs-CRP plasma concentration changes
Time frame: 12, 24, 48 weeks
Mean Total Cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, apolipoprotein, triglycerides, and apolipoprotein (apo) Al, B and E levels
Time frame: 12, 24, 48 weeks
Mean biomarkers of inflammatory process (fibrinogen, S-VCAM-1, adiponectin, CCL2, CCL3, d-dimer, IL-6, TNF-alpha, Lp-PLA2) changes
Time frame: 12, 24, 48 weeks
Clinical MACE: cardiovascular mortality, stroke, acute coronary syndromes, any cardiac arrhythmias, hospitalisation for cardiovascular causes, peripheral artery disease, revascularization.
Time frame: one year
Results and safety
The study was stopped early (reason given: Withdrawal of IMP from the market. Data on risk-benefit ratio pending.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Background: PubMed 15843671Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
- Background: PubMed 8074832Stemme S, Hansson GK. Immune mechanisms in atherogenesis. Ann Med. 1994 Jun;26(3):141-6. doi: 10.3109/07853899409147881.
- Background: PubMed 10093977Ledergerber B, Egger M, Opravil M, Telenti A, Hirschel B, Battegay M, Vernazza P, Sudre P, Flepp M, Furrer H, Francioli P, Weber R. Clinical progression and virological failure on highly active antiretroviral therapy in HIV-1 patients: a prospective cohort study. Swiss HIV Cohort Study. Lancet. 1999 Mar 13;353(9156):863-8. doi: 10.1016/s0140-6736(99)01122-8.
- Background: PubMed 16878047Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16.
- Background: PubMed 17944688Bonnet F, Chene G, Thiebaut R, Dupon M, Lawson-Ayayi S, Pellegrin JL, Dabis F, Morlat P; Groupe d'Epidemiologie Clinique du SIDA en Aquitaine (GECSA). Trends and determinants of severe morbidity in HIV-infected patients: the ANRS CO3 Aquitaine Cohort, 2000-2004. HIV Med. 2007 Nov;8(8):547-54. doi: 10.1111/j.1468-1293.2007.00508.x.
- Background: PubMed 17305648Sterne JA, May M, Bucher HC, Ledergerber B, Furrer H, Cavassini M, Bernasconi E, Hirschel B, Egger M; Swiss HIV Cohort. HAART and the heart: changes in coronary risk factors and implications for coronary risk in men starting antiretroviral therapy. J Intern Med. 2007 Mar;261(3):255-67. doi: 10.1111/j.1365-2796.2006.01761.x.
- Background: PubMed 19425222Calmy A, Gayet-Ageron A, Montecucco F, Nguyen A, Mach F, Burger F, Ubolyam S, Carr A, Ruxungtham K, Hirschel B, Ananworanich J; STACCATO Study Group. HIV increases markers of cardiovascular risk: results from a randomized, treatment interruption trial. AIDS. 2009 May 15;23(8):929-39. doi: 10.1097/qad.0b013e32832995fa.
- Background: PubMed 19954384Baker J, Ayenew W, Quick H, Hullsiek KH, Tracy R, Henry K, Duprez D, Neaton JD. High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection. J Infect Dis. 2010 Jan 15;201(2):285-92. doi: 10.1086/649560.
- Background: PubMed 19415282Montecucco F, Mach F. Update on statin-mediated anti-inflammatory activities in atherosclerosis. Semin Immunopathol. 2009 Jun;31(1):127-42. doi: 10.1007/s00281-009-0150-y. Epub 2009 May 5.
- Background: PubMed 9603539Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation. 1998 May 12;97(18):1837-47. doi: 10.1161/01.cir.97.18.1837.
- Background: PubMed 12486414Gotto AM Jr. High-density lipoprotein cholesterol and triglycerides as therapeutic targets for preventing and treating coronary artery disease. Am Heart J. 2002 Dec;144(6 Suppl):S33-42. doi: 10.1067/mhj.2002.130301.
- Background: PubMed 17935553Thoenes M, Oguchi A, Nagamia S, Vaccari CS, Hammoud R, Umpierrez GE, Khan BV. The effects of extended-release niacin on carotid intimal media thickness, endothelial function and inflammatory markers in patients with the metabolic syndrome. Int J Clin Pract. 2007 Nov;61(11):1942-8. doi: 10.1111/j.1742-1241.2007.01597.x.
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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.
Alexandra Calmy, MD principal investigator
University Hospital, Geneva
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing niacin/laropiprant in people with HIV and Atherosclerosis, run by Calmy Alexandra at 7 sites in Switzerland.
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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Withdrawal of IMP from the market. Data on risk-benefit ratio pending.). Results are not available in the source record.
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?
change in mean common carotid intima-media thickness (time frame: 48 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 NCT01683656, which also lists 25 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 8 Oct 2019.