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NCT ID: NCT01525238 Completed - Clinical trials for Type 2 Diabetes Mellitus

PK Study of Dapagliflozin in Pediatric Subjects With T2DM

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

The purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

NCT ID: NCT01524276 Recruiting - Clinical trials for Coronary Artery Disease

Product Surveillance Registry

PSR
Start date: January 2012
Phase:
Study type: Observational

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

NCT ID: NCT01523587 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Start date: March 5, 2012
Phase: Phase 3
Study type: Interventional

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

NCT ID: NCT01521923 Completed - Clinical trials for Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

C-early
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

NCT ID: NCT01519947 Completed - Clinical trials for Anemia, Kidney Disease, Chronic

A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

ALTITUD
Start date: May 30, 2012
Phase: Phase 4
Study type: Interventional

This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.

NCT ID: NCT01519791 Completed - Clinical trials for Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

C-early
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

NCT ID: NCT01519661 Completed - Clinical trials for Pulmonary Infections

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

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

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

NCT ID: NCT01517698 Completed - Fragile X Syndrome Clinical Trials

A Study of RO4917523 in Patients With Fragile X Syndrome

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

NCT ID: NCT01516541 Completed - Clinical trials for Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

A Study of Dalcetrapib in Patients With Stable Coronary Heart Disease, With Coronary Heart Disease Risk Equivalents or at Elevated Risk for Cardiovascular Disease

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

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.

NCT ID: NCT01515423 Completed - Schizophrenia Clinical Trials

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

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

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.