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NCT ID: NCT00699998 Completed - Clinical trials for Acute Coronary Syndrome

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

TRILOGY ACS
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

NCT ID: NCT00697424 Completed - Clinical trials for Sleep Apnea, Obstructive

Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography

Start date: May 2008
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. Epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing. The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which consists of pressurized air applied to the nose via a mask. Generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (SDB) events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal. Due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare providers can use this reported data to make appropriate treatment decisions. For this reason the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto adjusting CPAP which stores comprehensive compliance data. The aim of this study is to compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG in detecting sleep disordered breathing. Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of sleep disordered breathing.

NCT ID: NCT00692770 Completed - Clinical trials for Carcinoma, Hepatocellular

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

STORM
Start date: August 15, 2008
Phase: Phase 3
Study type: Interventional

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

NCT ID: NCT00689936 Completed - Multiple Myeloma Clinical Trials

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma

FIRST
Start date: August 21, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

NCT ID: NCT00686868 Completed - Clinical trials for Arthritis, Rheumatoid

Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

Start date: June 13, 2008
Phase: Phase 1
Study type: Interventional

This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.

NCT ID: NCT00680446 Completed - Clinical trials for Primary Immune Deficiency

Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

Start date: April 2008
Phase: Phase 3
Study type: Interventional

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

NCT ID: NCT00680186 Completed - Thromboembolism Clinical Trials

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

RE-COVER II
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

NCT ID: NCT00679588 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

SAVE-ABDO
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

NCT ID: NCT00674817 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs.

Start date: April 1, 2008
Phase: Phase 2
Study type: Interventional

GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in the presence of the short acting beta agonist salbutamol and the short acting muscarinic antagonist, ipratropium bromide will be measured in this study. Any residual bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic components of GSK961081

NCT ID: NCT00674635 Completed - Clinical trials for Arthritis, Rheumatoid

Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided into 2 parts: Part A is an adaptive, dose finding phase which will provide safety, tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions of a selected dose level.