There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.
Objective: The objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart failure. Design: The investigators are planning a study aiming at establishing proof of concept that treatment of patients with HF with Mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. The investigators are performing a combined dose-finding - chronic efficacy study. The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is 6 months. 70 patients with chronic heart failure will be included. Specific aims 1. Determine safety of administration of Mirabegron to patients with heart failure. 2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure. 3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure. 4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure. 5. Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.
A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
Cardiovascular disease remain one of the leading causes of death in Australia, accounting for 47637 (36%) of deaths in 2004. Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by intermittent claudication. This is defined as walking induced pain, cramping, aching, tiredness or heaviness in one or both legs that does not go away with continued walking and is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years suffer from claudication. The primary and most effective treatment for these patients is focused on improving walking ability and functional status. Current research has shown that approximately 30% of patients improve with exercise, while 30% continue to deteriorate and the rest show no change. The changes produced at a biochemical and cellular level due to exercise are unknown. To help better understand this, our study will assess the entire range of proteins expressed before and after exercise in the skeletal muscle tissue of patients with intermittent claudication. This will help to identifying key proteins that have a role in improving patient symptoms and outcome.