Imed19-private research

Experienced research partner

Medical progress requires clinical research center.

In order to be able to treat diseases better through the development of new therapies, efficacy and safety for humans must be proven. Clinical trials are essential for this. Every clinical trial must be approved by the responsible ethics committee before it begins. Participation in the trial is voluntary. Your participation will potentially give you early access to new therapies that would not be available outside of the trial. Your participation in the trial can advance medical progress and improve the treatment of future patients.

Information for patients

Service

The Imed19-privat research center is located in the premises of the Imed19-privat and has modern and certified equipment, such as a refrigerated centrifuge, -20 degrees and -80 degrees Celsius freezers for the professional conduction of clinical trials. Scheduling and supervision of follow-up visits are carried out by our specially employed, highly qualified study nurse. She is responsible for entering data into the eCRF and organizes the administration and distribution of the study drug to the participants.

The infrastructure of Imed19-privat clinical research center is also available to interested investigators as a platform for conducting clinical studies. The investigator contract is concluded between the study sponsor and Imed19 Betriebs GmbH as an institution / trial center. You are local principal investigator with all associated rights and obligations. The costs for the platform and Study Nurse are based on the terms and conditions agreed upon in the clinical agreement.

Among other things, we offer echocardiography, (spiro) ergometry, pharmacokinetic sampling including shipping or -80 ° C storage.

medical lead

Priv.-Doz. Dr. Christopher Adlbrecht, MBA, FHFA, FESC

In 2011 Dr. Adlbrecht received the “Young Investigators Award” from the American College of Cardiology (ACC) in clinical research and was Associate Professor of Internal Medicine at the University Clinic for Internal Medicine II, Department of Cardiology at the Medical University of Vienna (AKH Vienna) until November 2016 . He has published around 80 scientific papers through international research cooperation and project funding, including the Austrian National Bank and the Medical and Scientific Fund of the Mayor of Vienna. As an external lecturer, Dr. Adlbrecht teaches in the PhD program “Endocrinology and Metabolism” at Medical University of Vienna.

  • A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) NCT02861534
  • Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 NCT01563263
  • Proteomic Profiling to Reveal Novel Prognostic Markers for Neurological Outcome Following Resuscitation NCT01960699; European Patent Office Application # EP18214021.0
  • Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes NCT02556203
  • Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction NCT01920711
  • A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction NCT03098979
  • Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention NCT02866175
  • Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF NCT03547583
  • Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI NCT02924727
  • Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF) NCT02943785
  • A Trial to Study BAY1753011 in Patients With Congestive Heart Failure NCT03901729
  • Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications. NCT04218266
  • Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD NCT04023552

Priv.-Doz. Dr. Wolfgang Sieghart

Dr. Sieghart was Associate Professor of Internal Medicine, Gastroenterology and Hepatology at the Medical University of Vienna (AKH Vienna) until April 2017 and headed the Liver Cancer (HCC) research group there. He has served as principal investigator and subinvestigator in numerous academic and industry sponsored phase 1-3 drug trials.

SOLAR-2 Sofsbuvir/ledipasvir/Ribavirin in patients with HCV cirrhosis pre/post liver transplantation (Industrie gesponsert)

HIVCOPEG: Treatment of HCV/HIV co-infected patients with PegInterferon alpha 2a and
Ribavirin (Academic study)

SORATACE-1: Combination of Sorafenib and cTACE in patients with HCC (completed)
AVATACE-1: Combination of Bevacizumab and cTACE in patients with HCC (completed)

Principal investigator (on site)

Phase III: CA209459: A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma

REACH-2 Trial: Ramucirumab versus Placebo in patients with AFP >400ng/l who failed sorafenib treatment

ARQ197-A-U303: Tivantinib versus Placebo in patients with advanced HCC who failed prior systemic therapy with sorafenib

Doxorubicin Transdrug® in Advanced HepatoCellular Carcinoma after failure or intolerance to Sorafenib. A Randomized, Multicentre Phase 3 Study

Subinvestigator (on site) in first and second line

Phase III: SEARCH, SORAMIC, EVOLVE-1, REACH-1, SACC-trial,

Phase II: SPACE, BIBF-1120 (Vargatef) in patients with advanced HCC, Refametinib

Phase I: BIBF-1120 (Vargatef) in patients with advanced HCC

Univ.-Prof. PD Dr. Martin Schillinger

Univ.-Prof. PD Dr. Martin Schillinger

Clinical and research priorities of Prof. Schillinger are the diagnosis and therapy of circulatory disorders in the heart, brain and legs as well as their risk factors (high blood pressure, diabetes, increased blood lipids). The minimally invasive treatment of these diseases using catheter technology (“cardiac catheter”, “vascular catheter”) is of particular importance here. The subject combination of angiology (vessels) and cardiology (heart) guarantees holistic diagnosis and therapy of cardiovascular diseases, as these usually occur together. Prof. Schillinger is the author and co-author of over 200 original scientific papers, including numerous papers in highly renowned international journals such as the New England Journal of Medicine, editorials in JAMA and the editor of several books and numerous book chapters. In 2010, Prof. Schillinger was one of only two Austrian researchers among the 50 most cited German-speaking scientists in his field of research worldwide. Prof. Schillinger works internationally as a scientific reviewer and is a member of numerous editorial boards of international specialist journals. Extensive teaching and lecturing activities with over 100 lecture tours led him to many European countries as well as to the USA. In addition, Prof. Schillinger acts as a consultant to numerous American and European companies in the field of catheter technology and stent implantation (vascular supports) and thus contributes to the development of the latest technologies.

Currently recruiting clinical trials

Lp(a)FRONTIERS CAVS

A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis.

Study Details:

Lp(a)FRONTIERS CAVS

HERMES

Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation.

Study Details:

HERMES

MIRO-CKD Study

A Phase IIb, Multicentre, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination with Dapagliflozin Compared with Dapagliflozin in Patients with Chronic Kidney Disease and Albuminuria.

Study Details:

MIRO-CKD

TRIUMPH-OUTCOMES – GZBO

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.

TRIUMPH-OUTCOMES – GZBO

Contact form for patients

clinical trials with completed recruitment

Victorion-1-Prevent

Trial of Inclisiran to prevent cardiovscular events in high-risk primary prevention patients.

Study details:

Victorion-1-Prevent

FINEARTS-HF

Trial on finerenone in heart failure with preserved systolic function.

Study details:

FINEARTS-HF

STEP HFpEF DM

Trial in patients with heart failure and preserved systolic function, obesity, and type II diabetes mellitus.

Study details:

STEP-HFpEF DM

REDEFINE 2

Study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weight.

Study details:

REDEFINE 2

PONTIAC II

Trial on the application of inhibitors of the renin-angiotensin system and ß-blockers in target doses in heart healthy people with diabetes.

Study details:

PONTIAC II

VICTOR

Trial of vericiguat in patients with stable heart failure and reduced systolic function.

Study details:

VICTOR

Resistant Hypertension

Study on efficacy, safety, tolerability and dose finding of XXB750 administered as subcutaneous injections in resistant hypertension patients.

Study details:

Resistant Hypertension

CARE-HK in HF Registry

Cardiovascular and renal treatment in heart failure patients with hyperkalaemia or at high risk of hyperkalaemia.

Study details:

CARE-HK in HF

RETRO NIS Registry

Retrospective assessment of inclisiran adherence, treatment patterns, patient characteristics, and effectiveness among ASCVD patients with hypercholesterolemia, ASCVD-risk equivalent patients with hypercholesterolemia and familial HypercholesteROlemia patients prescribed LEQVIO® (inclisiran) in a real-world setting.

RETRO NIS

General information on clinical trials

Clinical trials improve the treatment of a disease and in some cases make it possible in the first place.

Before a drug is available in a pharmacy and can be prescribed for therapy by a doctor, it must go through several stages. After a series of preclinical tests, drugs are put into what is known as clinical testing. This means that their safety and efficacy are tested on humans. This process is divided into several phases.

In phase I, healthy people receive the substance to test tolerance.

Phase II is used to determine the most suitable dosage and effectiveness in humans for a specific disease.

In phase III, the findings of phase II with regard to the safety and effectiveness of the drug are tested on a large number of people with a specific disease. The results of the III. phase are decisive for market approval (“pivotal trial”).

In a fourth phase, which is carried out in some cases (after the drug has been approved), additional data can be collected. The main purpose of this is to identify any rarely occurring side effects.

Clinical trials are carried out internationally according to comparable rules and processes. The basis for this are agreements to which both the “sponsor”, usually a pharmaceutical company or a medical device manufacturer, and also the investigators must adhere. The respective competent authorities are the Federal Office for Safety in Health Care (BASG) and the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) .

The actual possibility of participating in a trial also depends on strict inclusion and exclusion criteria. In a detailed discussion, the potential participant is informed about the drug, including potential risks and the course of the trial. After agreeing and signing the informed consent form the participant may be included into the trial.

Unwanted side effects can occur both in the context of the clinical trial, but also in the subsequent routine prescription and use of a drug. These can be identified at an early stage through close medical checks in the clinical trial process. In addition to the data that are decisive for the approval of the drug, the health and wellbeing of the paticipant is always the focus.

Participation in a clinical trial is essential for advancement in medicine. Study patients can be part of this progress and at the same time receive early access to medication that is not (yet) prescribable, accompanied by an investigator. The study patients are cared for by our experienced and professionally trained study team in a pleasant atmosphere in the modern Imed19-private clinical research center.

Recent trials

We are here for you

Are you interested in participating in a clinical trial? Contact us – we look forward to speaking to you personally!

Or call us:

+43 1 367 13 73

Monday – Thursday:
8:00 a.m. – 6 p.m.,
Friday:
8:00 – 12:00 a.m.

Fax: +43 1 367 13 73-73

Links

Visit our profile at
InvestigatorDatabank (for study sponsors – login required)

Scientific cooperation partner of the Medical University of Vienna

European Medicines Agency – SPOR