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NCT ID: NCT00880737 Completed - Pulmonary Embolism Clinical Trials

Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism

PROTECT
Start date: February 2009
Phase: N/A
Study type: Observational

The objectives of the PROTECT study are: - To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE). - To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE. - To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE. - To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE. - To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

NCT ID: NCT00880724 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

European Multi-center Post Market Study of the IBV Valve System

IBV
Start date: March 2007
Phase: N/A
Study type: Interventional

The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.

NCT ID: NCT00880308 Completed - Clinical trials for Basal Cell Carcinoma

Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Start date: March 2009
Phase: Phase 1
Study type: Interventional

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.

NCT ID: NCT00880269 Completed - Clinical trials for Acute Myelogenous Leukemia

Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Start date: August 2009
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

NCT ID: NCT00879905 Completed - Clinical trials for Advanced Solid Malignancies

A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

Start date: May 2009
Phase: Phase 1
Study type: Interventional

This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.

NCT ID: NCT00879658 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

Start date: March 30, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study. Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies. The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes [Polman, 2008]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models. Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).

NCT ID: NCT00879333 Completed - Clinical trials for Advanced Gastric Cancer

Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)

GRANITE-1
Start date: July 2009
Phase: Phase 3
Study type: Interventional

This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

NCT ID: NCT00878709 Completed - Breast Cancer Clinical Trials

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

ExteNET
Start date: July 9, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

NCT ID: NCT00877929 Completed - Hypertension Clinical Trials

Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

Start date: February 2009
Phase: Phase 3
Study type: Interventional

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

NCT ID: NCT00877474 Completed - Clinical trials for ADVANCED SOLID TUMORS

Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors

Start date: March 2009
Phase: Phase 1
Study type: Interventional

This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors