Chermside, Australia Clinical Trials

Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i. REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in ...

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 2% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will ...

To provide access to palbociclib to post-menopausal patients with hormone receptor-positive [HR(+)], HER2-negative [HER2(-)] ABC who are deemed appropriate for letrozole therapy.

The purpose of this study is to generate initial insights into the safety and performance of the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral regurgitation who are not suitable candidates for conventional mitral valve repair or replacement. The study will include up to 350 subjects ...

This study has two arms: Arm 1 (EGF816 + nivolumab) is currently closed to new enrollment. Arm 2 (INC280 + nivolumab) is open and enrolling as planned.

This is an open-label, staggered dose-escalation, cohort expansion study that will enroll subjects at multiple study sites in the United States of America (USA) and Australia. The study will consist of two treatment arms: - Low dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks. - ...

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses ...

The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70 investigational sites. The study is powered to analyze the high risk cohort and extreme risk cohort together against a commercially available control for the primary safety and effectiveness endpoints. In addition, data for each cohort will ...

The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.