Clinical Trials Logo

Filter by:
NCT ID: NCT01896531 Completed - Gastric Cancer Clinical Trials

A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Start date: August 14, 2013
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.

NCT ID: NCT01896284 Completed - Clinical trials for Wet Macular Degeneration

Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor

MACBETH
Start date: July 2013
Phase: Phase 4
Study type: Interventional

Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01894919 Completed - Clinical trials for Meningococcal Meningitis

Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28

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

The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study.

NCT ID: NCT01894893 Completed - Clinical trials for Breastfeeding Mothers

Atlas of Human Milk Nutrients

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

The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are: 1. To assess whether there is a correlation between human milk composition and mothers' diet 2. To assess whether there is a correlation between human milk composition and maternal clinical parameters 3. To assess whether there is a correlation between human milk composition and mother and infant clinical parameters

NCT ID: NCT01894529 Completed - Ischemic Stroke Clinical Trials

Immunological Biomarkers in Patients With Acute Ischemic Stroke

Start date: January 2010
Phase: N/A
Study type: Observational

Stroke is accompanied by local inflammatory response and systemic immunosuppression. Immunosuppression markers are associated with the occurrence of medical complications (infections), whereas inflammatory markers are associated with worse functional prognosis. This prospective study tries to validate in acute stroke patients the prognostic usefulness of a panel of immune biomarkers that have previously been associated with various clinical outcomes. The identification of beneficial and harmful immune responses in cerebral ischemia will allow the prediction of the clinical course of the patients and will be helpful in designing immunomodulatory therapeutic strategies for acute stroke.

NCT ID: NCT01894516 Completed - Clinical trials for Rheumatoid Arthritis

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Start date: October 8, 2013
Phase: Phase 2
Study type: Interventional

- Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. - During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.

NCT ID: NCT01894022 Completed - Hypertension Clinical Trials

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

AMBER II
Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: - The product is approved locally for use in inoperable CTEPH patients; - Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities - The investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.