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NCT ID: NCT01676935 Terminated - Alzheimer's Disease Clinical Trials

This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is a long term extension study to evaluate safety and tolerability of subjects who complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

NCT ID: NCT01673984 Terminated - Prostate Cancer Clinical Trials

GP Extended Action Triptorelin

GREAT
Start date: August 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

NCT ID: NCT01673386 Terminated - Clinical trials for Metastatic Renal Cell Carcinoma

A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

TAURUS
Start date: July 2012
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

NCT ID: NCT01673360 Terminated - Clinical trials for Pelvic Organ Prolapse

Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

CAPTURE
Start date: September 2012
Phase: N/A
Study type: Observational

To monitor post-market performance through evaluation of short and long-term performance via: - Efficacy - Safety - Patient reported outcomes

NCT ID: NCT01672879 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

NASH
Start date: October 29, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01672866 Terminated - Clinical trials for Liver Fibrosis Due to NASH

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Start date: December 5, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: - Randomized Double-Blind Phase - Open-Label Phase (optional)

NCT ID: NCT01671111 Terminated - Clinical trials for Iron Overload Due to Repeated Red Blood Cell Transfusions

Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)

Start date: August 14, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload

NCT ID: NCT01668550 Terminated - Clinical trials for Advanced Solid Tumours

A Phase I Study of AZD0424 Alone and in Combination in Advanced Solid Tumours

AZD0424
Start date: October 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose of the oral Src/Abl inhibitor AZD0424, and to find tolerable and effective AZD0424 combination regimens for the treatment of advanced solid tumours

NCT ID: NCT01667146 Terminated - Clinical trials for Acute Respiratory Distress Syndrome

A Multi-centre Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome

PHARLAP
Start date: October 2012
Phase: N/A
Study type: Interventional

Some people develop the condition called acute respiratory distress syndrome (ARDS). This is a condition where the lungs have become injured from one of a number of various causes, and do not work as they normally do to provide oxygen and remove carbon dioxide from the body. This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS are admitted to the intensive care unit (ICU) and need help with their breathing by being connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the body causing other problems but also death. Over the past few years, reducing the size of each breath delivered by the ventilator in conjunction with the use of an occasional sustained deep breath called a "recruitment manoeuvre" have been used to try to prevent further damage to the lungs in people with ARDS. This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research study to have some beneficial effects without causing any obvious harm, when compared to a current best practice ventilator strategy. The main beneficial effects of the PHARLAP strategy were to increase the amount of oxygen in the blood and to reduce markers of inflammation (the body reacting to a disease process) in the body. This study was too small to make a strong conclusion, so this study will be much larger and will assess whether patients who have developed ARDS are better off when we use the PHARLAP strategy. Three hundred and forty patients will be enrolled into this study in multiple ICUs across Australia and New Zealand. The study hypothesis is that the PHARLAP strategy group will have a higher number of ventilator free days at day 28 than the control group.

NCT ID: NCT01662726 Terminated - Breast Neoplasms Clinical Trials

A Study to Assess the Ability of a Novel Endocrine Treatment for Breast Cancer, Irosustat, to Slow Down Cancer Growth

IPET
Start date: August 2012
Phase: Phase 2
Study type: Interventional

This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether. IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. FLT-PET scans will be performed before and following treatment with Irosustat. As cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer. Blood samples will be taken at regular intervals to assess what the new drug does to the body and the safety and tolerability of Irosustat will be assessed. The study incorporates translation aspects/endpoints which are based on the collection of tumour biopsies before and after treatment with Irosustat although the later biopsy is not mandatory.