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NCT ID: NCT01584739 Terminated - COPD Clinical Trials

AZD8683 Multiple Dose Study in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: June 2012
Phase: Phase 1
Study type: Interventional

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.

NCT ID: NCT01583114 Terminated - Clinical trials for Dilated Cardiomyopathy

PREclinical Mutation CARriers From Families With DIlated Cardiomyopathy and ACE Inhibitors

PRECARDIA
Start date: December 2011
Phase: Phase 3
Study type: Interventional

This is a multicentre European double-blind,randomized and controlled trial with 2 parallel groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated cardiomyopathy). Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation (leading to a genetic form of heart failure) but have not yet developed DCM. Context. Dilated Cardiomyopathy (DCM) is one of the leading causes of Heart Failure due to systolic dysfunction and at least 30% of DCM are of familial/genetic origin, usually with autosomal dominant inheritance, and underlying genes and mutations are increasingly identified. Familial Dilated Cardiomyopathy (fDCM) is characterized by age-related penetrance (or delayed-onset), that means that the cardiac expression of the disease (echocardiographic abnormalities) is usually absent for a long period and progressively appears with advanced age, usually after 20 years of age Hypothesis : ACEi may delay or prevent the occurrence of DCM in these subjects (pre-clinical stage). Expected results: If the hypothesis is confirmed, and as a consequence, the knowledge derived from basic research (genes identification in DCM) will be translated into clinical practice (early identification of subjects at high risk of developing heart failure through predictive genetic testing) with the development of new therapeutic management (early ACEi) that will help to decrease the morbidity and mortality associated with the disease. This will constitute a paradigm of the development of preventive medicine thanks to the development of genetics in the cardiovascular field. Subjects who are concerned are ≥18 years of age and ≤60 years, carry a mutation responsible for DCM and are at a preclinical stage of the disease. Total duration of treatment (perindopril versus placebo) is 3 years. A total number of 200 participants will be enrolled (100 in each group) in 7 centres.

NCT ID: NCT01582672 Terminated - Clinical trials for Renal Cell Carcinoma

Phase 3 Trial of Autologous Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

ADAPT
Start date: November 2012
Phase: Phase 3
Study type: Interventional

This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

NCT ID: NCT01581060 Terminated - Clinical trials for Advanced Solid Tumours

Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of chronic treatment with WX-554.

NCT ID: NCT01573247 Terminated - Clinical trials for Acute Myeloid Leukemia

Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia

Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.

NCT ID: NCT01573156 Terminated - Renal Cancer Clinical Trials

Vascular Targeted Photodynamic Therapy T1a Renal Tumours

KCM201
Start date: May 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Vascular Targeted Photodynamic therapy (VTP) with the Vascular Occluding Agent (VOA) WST11, may offer an alternative, providing tumour destruction via a minimally invasive approach. In this investigation, the investigators plan to use the WST11 VTP procedure to treat a predetermined small renal tumour targets. Patients will be given a general anaesthetic, to ensure immobility, and prevent discomfort during treatment sessions. Treated patients will then undergo surgical resection of their tumours, and the accuracy and reliability of tissue death with VTP will be assessed histologically. The aim of this proof of concept study is to demonstrate whether this modality has potential for a clinical role in the treatment of oncological kidney disease, either as an alternative to surgery, or where surgery is not feasible.

NCT ID: NCT01571635 Terminated - Clinical trials for Beta Thalassemia Major

Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta( β)- Thalassemia.

Start date: October 10, 2012
Phase: Phase 2
Study type: Interventional

Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

NCT ID: NCT01570361 Terminated - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Progression Trial

ATTEST
Start date: February 13, 2012
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

NCT ID: NCT01568229 Terminated - Schizophrenia Clinical Trials

20110165: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms (Study 165)

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

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

NCT ID: NCT01562899 Terminated - Clinical trials for Metastatic Pancreatic Adenocarcinoma

A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

Start date: August 27, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.