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NCT ID: NCT01126437 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Start date: May 2010
Phase: Phase 3
Study type: Interventional

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

NCT ID: NCT01125722 Completed - Overactive Bladder Clinical Trials

Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

Start date: April 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.

NCT ID: NCT01125189 Completed - Hepatitis C Virus Clinical Trials

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

HEPCAT
Start date: July 2010
Phase: Phase 2
Study type: Interventional

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

NCT ID: NCT01124786 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

NCT ID: NCT01122446 Completed - Type 1 Diabetes Clinical Trials

Diabetes Prevention - Immune Tolerance

DIAPREV-IT
Start date: April 2009
Phase: Phase 2
Study type: Interventional

A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell autoantibodies Eligible children are 4 years or older, have positive GAD-antibodies and at least one additional autoantibody and not yet diabetes. Objectives: DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset of type 1 diabetes. The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1 diabetes. The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta-cell autoimmunity as indicated by multiple positive islet cell autoantibodies.

NCT ID: NCT01121887 Completed - Smoking Cessation Clinical Trials

Telephone-based Treatment for Smoking Cessation

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Aim: to assess the effect of adding Motivational Interviewing (MI) to the existing smoking cessation treatment protocol at the Swedish National Tobacco Quitline (SNTQ). Methods: Experienced counsellors at SNTQ either received further training in the standard treatment (ST) protocol (including Cognitive Behavioural Therapy (CBT)) or a comprehensive regime of training in MI. 1309 clients were randomized to either the ST group or the group with MI added to the treatment protocol. In order to ensure treatment integrity among counsellors, MI skill was assessed using the Motivational Interviewing Treatment Integrity Code (MITI).

NCT ID: NCT01121406 Completed - Ovarian Neoplasms Clinical Trials

BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This is an international, randomized phase II trial. The aim is to assess the efficacy and the safety of BI 6727 Versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. 100 patients will be randomised at the study entry to receive either BI 6727 (Arm A: 50 patients) or non-platinum single agent cytotoxic (Arm B: 50 patients) Treatment will be continued until disease progression or unacceptable toxicity. Primary endpoint: disease control rate at week 24 according to Response Evaluation Criteria In Solid Tumours version 1.1. Secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum CA 125 according to Gynecologic Cancer Intergroup criteria, safety according to the NCI CTCAE v.3, disease symptoms control assessed by the EORTC QLQ-C30, QLQ-OV28 and individual symptoms questionnaires, pharmacokinetics of BI 6727. Others endpoints: biomarkers and pharmacogenetics analysis (optional)

NCT ID: NCT01121315 Completed - Diabetes Type II Clinical Trials

A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care

ROSE
Start date: May 2010
Phase: N/A
Study type: Observational

To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.

NCT ID: NCT01120301 Completed - Clinical trials for Acute Ischemic Stroke

Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

NEST-3
Start date: September 2010
Phase: Phase 3
Study type: Interventional

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

NCT ID: NCT01120184 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

Start date: July 31, 2010
Phase: Phase 3
Study type: Interventional

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.