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NCT ID: NCT01816295 Completed - Hypogonadism Clinical Trials

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

NCT ID: NCT01816230 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM

Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.

NCT ID: NCT01815840 Completed - Clinical trials for Basal Cell Carcinoma

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Start date: April 30, 2013
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

NCT ID: NCT01815736 Completed - HIV Infections Clinical Trials

Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

Start date: March 27, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

NCT ID: NCT01815294 Completed - Neoplasms Clinical Trials

A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer

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

The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).

NCT ID: NCT01814943 Completed - Clinical trials for Uncomplicated Peptic Ulcer

The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

Start date: November 2012
Phase: N/A
Study type: Observational

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained. The aims of the post hoc analyses are: To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA. To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

NCT ID: NCT01814163 Completed - Clinical trials for Nonsquamous Nonsmall Cell Neoplasm of Lung

Observational Post-authorization Studies Carboplatin, Paclitaxel and Bevacizumab

ANGIOMET
Start date: February 2011
Phase: N/A
Study type: Observational

This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.

NCT ID: NCT01813721 Completed - Clinical trials for Chemotherapy-induced Febrile Neutropenia

Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

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

This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

NCT ID: NCT01813435 Completed - Clinical trials for Coronary Artery Disease (CAD)

GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

Start date: July 1, 2013
Phase: Phase 3
Study type: Interventional

After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications. There are two medication strategies: - Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR - Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

NCT ID: NCT01813422 Completed - Clinical trials for Hypercholesterolemia

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

GLAGOV
Start date: April 18, 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.