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NCT ID: NCT01715818 Completed - Clinical trials for Cardiovascular Disease, Diabetes Mellitus Type 2

A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

Start date: December 2012
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

NCT ID: NCT01715493 Completed - Asthma Clinical Trials

Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom

Start date: October 2012
Phase: Phase 4
Study type: Interventional

The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.

NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01714843 Completed - Clinical trials for Constipation-predominant Irritable Bowel Syndrome (IBS-C)

A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Start date: August 10, 2012
Phase: Phase 2
Study type: Interventional

This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.

NCT ID: NCT01713946 Completed - Clinical trials for Tuberous Sclerosis Complex-associated Refractory Seizures

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

EXIST-3
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

NCT ID: NCT01713491 Completed - Dementia Clinical Trials

Pre-stroke Cognitive Status and Thrombolytic Therapy

OPHELIE-COG
Start date: November 2011
Phase: N/A
Study type: Observational

At the acute stage of cerebral ischaemia, the only effective drug that increases the proportion of patients who survive without dependency is thrombolytic therapy by intravenous (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice with similar results than in trials, in various places of the world including Europe and Japan. Stroke and dementia are closely related. About one patient in ten has dementia before a first-ever stroke, and more than one in three has dementia after a recurrent stroke. Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing cognitive impairment without dementia is associated with a higher rate of institutionalisation within 3 years. In many patients cognitive impairment is due to the summation of the effects of vascular and Alzheimer lesions of the brain. More and more patients nowadays who are eligible for rt-PA are already known as demented at admission. A retrospective study conducted in a cohort of patients with dementia who had an ischaemic stroke and were treated by rtPA suggested that there is no increased risk of cerebral bleeding and death as compared with non demented patients. However, pre-existing cognitive impairment is possibly associated with (i) an increased risk of bleeding in patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of rt-PA on the brain tissue. Japanese patients differ from European patients by a higher risk of spontaneous intracranial haemorrhage, and a higher proportion of patients with small-vessel diseases. The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment or dementia. The secondary objectives are to determine whether (i) they have an increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a poor outcome is lower than expected from the placebo group of randomised trials for patients with a similar range of baseline severity, and (iii) the influence of the cognitive state on outcome differs between Japanese and European patients.

NCT ID: NCT01713387 Completed - Clinical trials for Biliary Tract Cancer

A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

Start date: April 2012
Phase: Phase 1
Study type: Interventional

To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1 combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy

NCT ID: NCT01713075 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for Chronic Obstructive Pulmonary Disease (COPD) Patients

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

The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the post-marketing actual use.

NCT ID: NCT01712802 Completed - Edentulous Clinical Trials

Multicenter Study of Denture Adhesive

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

To establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out. The null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.

NCT ID: NCT01711840 Completed - Bronchial Asthma Clinical Trials

Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy

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

The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.