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NCT ID: NCT00855465 Completed - Clinical trials for Pulmonary Hypertension

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

CHEST-1
Start date: February 23, 2009
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

NCT ID: NCT00855218 Completed - Clinical trials for Carcinoma, Hepatocellular

A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

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

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

NCT ID: NCT00853827 Completed - Clinical trials for Coronary Artery Disease (CAD)

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

AQUARIUS
Start date: March 2009
Phase: Phase 3
Study type: Interventional

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

NCT ID: NCT00853658 Completed - Clinical trials for Chronic Heart Failure

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure

ATMOSPHERE
Start date: March 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

NCT ID: NCT00853593 Completed - Heart Failure Clinical Trials

Model 4396 Left Ventricular (LV) Lead Study

4396
Start date: March 2009
Phase: N/A
Study type: Interventional

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

NCT ID: NCT00853580 Completed - Clinical trials for Neurofibromatosis Type 1

A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1

STARS
Start date: July 2009
Phase: Phase 2
Study type: Interventional

The specific aim of this study is to determine whether Lovastatin ™ significantly improves visual spatial learning and/or sustained attention in children with NF1. Secondary Aims: To evaluate the effect of Lovastatin ™ on measures of executive function, behavior and quality of life in children with NF1 and cognitive deficits. To further evaluate the toxicity and tolerability of Lovastatin ™ in children with NF1 and cognitive deficits. Hypotheses It is hypothesized that Lovastatin ™ will improve the visual spatial memory and/or attention deficits in children with NF1. This is based on studies demonstrating that Lovastatin ™ has significantly improved impairments in visual spatial memory and attention in the NF1 murine model. It is further expected that Lovastatin ™ will be safe and well tolerated over a 16-week period.

NCT ID: NCT00853385 Completed - Clinical trials for Rheumatoid Arthritis

A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

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

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

NCT ID: NCT00851084 Completed - Clinical trials for Colorectal Neoplasms

Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

AFFIRM
Start date: February 2009
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

NCT ID: NCT00850772 Completed - Clinical trials for Fallopian Tube Cancer

Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer

OPEN
Start date: January 2009
Phase: Phase 3
Study type: Interventional

Ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of appetite and reduced food intake. Being malnourished can contribute to the incidence and severity of cancer treatment side effects and increase the risk of infection. Currently patients with advanced ovarian cancer do not receive early nutrition using a feeding tube. The purpose of this study is to compare enteral nutrition along with standard post-surgery care against current standard post-operative care alone. This study will see if early nutrition using a feeding tube has an impact on length of hospital admission, recovery from surgery, complications from surgery, nutritional status and ultimately a reduction in treatment costs in people with Advanced Epithelial Ovarian Cancer (EOC). Primary Peritoneal Cancer (PPC) or Fallopian Tube Cancer. Nutritional support has been shown to ; - Prevent and treat under-nutrition, - Enhance anti-tumour treatment effects, - Reduce adverse effects of anti-tumour therapies, - Improve quality of life.

NCT ID: NCT00850538 Completed - Clinical trials for Osteoarthritis, Knee

Role of Bone in Knee Osteoarthritis (OA)

Start date: July 2008
Phase: N/A
Study type: Observational

The purpose of the study is to investigate protein and gene expression among damaged knee tissues. We will perform MRI's on subjects prior to total knee replacement to identify the location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus specimens normally discarded from total joint replacements will be used for live cell harvest, and protein and gene expression analyses of tissue or cultured cells.