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NCT ID: NCT01751776 Completed - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

Start date: December 18, 2012
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients. To explore the pharmacokinetic (PK) and pharmacodynamic (PD) parameters of multiple doses of BI 655064 in healthy volunteers (HVs) and rheumatoid arthritis (RA) patients. To assess clinical effect of BI 655064 in RA patients with prior inadequate response to methotrexate (MTX) after 12 weeks of treatment

NCT ID: NCT01751022 Completed - Heart Failure Clinical Trials

Attain Performa(TM) Quadripolar Lead Study

Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.

NCT ID: NCT01750918 Completed - Cancer Clinical Trials

BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)

Start date: December 19, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC. The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD for double (T+P) combination in Part 4A, and assess clinical activity of this combination in two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to anti-EGFR therapy).

NCT ID: NCT01750853 Completed - Healthy Volunteers Clinical Trials

A Study of LY3045697 in Healthy Participants

Start date: January 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of LY3045697 after a single dose, and to determine how long LY3045697 remains in the body. Two cohorts (groups) of 9 participants each will participate in 3 dosing periods. These participants will receive placebo in one period only. A third cohort of 9 will participate in 2 dosing periods and participants will receive either 2 dose levels of LY3045697 or 1 dose level of LY3045697 and placebo by the end of both periods.

NCT ID: NCT01750281 Completed - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

SELECT-2
Start date: December 18, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

NCT ID: NCT01746667 Completed - Clinical trials for Social Anxiety Disorder

Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Start date: February 2012
Phase: N/A
Study type: Interventional

The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.

NCT ID: NCT01746329 Completed - Obesity Clinical Trials

Tea-beetroot-venous Occlusion Plethysmography

Start date: December 2012
Phase: N/A
Study type: Interventional

In the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.

NCT ID: NCT01744561 Completed - Cystic Fibrosis Clinical Trials

Effects of a Partially Supervised Conditioning Program in CF

ACTIVATE-CF
Start date: July 1, 2014
Phase: N/A
Study type: Interventional

Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.

NCT ID: NCT01744236 Completed - Type 2 Diabetes Clinical Trials

SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies

Start date: April 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1 receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal systems in patients with Type 2 Diabetes Mellitus.

NCT ID: NCT01742286 Completed - Clinical trials for ALK-activated Tumors

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Start date: August 28, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.