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A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee

Primary ObjectiveTo demonstrate that the effectiveness of the NOVOCART® 3D plus autologouschondrocyte transplantation system is superior to microfracture for the treatment ofarticular cartilage defects of the knee by demonstrating superiority of the…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infection

Primary Objective(s) & HypothesisObjective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy…

Addition of Tobramycin inhalation antibiotic treatment to standard IV antibiotic treatment for ventilator-associated pneumonia

Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia.The initial response to treatment will be evaluated…

Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX)

1) To demonstrate that trans-radial intervention as compared to femoral access site is associated to lower rate of the composite endpoint of death, MI or stroke within the first 30 days after randomization in acute coronary syndrome patients…

Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack (RESUS-AMI)

The primary objective of the study will be to evaluate two low doses of a single intracoronary injection of rhIGF-1 compared with saline placebo on global LVEF by cardiac MRI and for safety (hypoglycaemia) in select subjects with STEMI and severe…

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator*s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…

Intervention study to assess the effect of daily consumption of a lutein-enriched-egg beverage on maintenance of visual function in subjects with early signs of Age-related Macular Degeneration

To assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of Age-related Macular Degeneration.

Pivotal Study for Safety & Efficacy of AltaSeal® A Hysteroscopically Placed Mechanical Occlusion Implant for Hysteroscopic Sterilisation

The primary objective of this clinical trial is to evaluate the safety and effectiveness of the AltaSeal® implants in providing bilateral mechanical occlusion of the fallopian tubes and in preventing pregnancy.Additional objectives are as follows:*…

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin as Adjunctive Therapy in Children 1 Month through <4 Years of Age with Partial Onset Seizures.

Primary Efficacy Objective* The primary objective of this study is to evaluate the efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

A 12-Week, Randomized, Double-Blind, Olive Oil-Controlled Phase 3
Study to Assess the Efficacy and Safety of EPANOVA* in Subjects With
Severe Hypertriglyceridemia

Primary ObjectivesThe primary objectives of the study are:· To determine the efficacy of Epanova 2 g daily compared to olive oil 2 g daily for 12 weeks in lowering serum TG levels in subjects with severehypertriglyceridemia (TG levels *500 mg/dL [5.…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

Safety and Performance Study of the Edwards CENTERA Self-Expanding
Transcatheter Heart Valve

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.

3.1 Primary Objective(s): 1) Objective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as…

A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF-04950615 IN SUBJECTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA AT RISK OF CARDIOVASCULAR EVENTS

A complete list of objectives is presented in Section 2.1 Objectives of the Study Protocol. In summary, the primary objective of this study is to demonstrate a superior LDL-C lowering effect of PF 04950615 150 mg administered by the SC route Q2wks…

A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

To assess the safety and efficacy, measured as progression free survival, of AZD9291 compared with platinum-based doublet chemotherapy in patients with EGFR mutation positive en T790M mutation positive, locally advanced or metastatic non small cell…

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)

Primary ObjectiveThe primary objective is to assess the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill…

A multicentre, international, phase 3, double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of daily oral dosing of tafamidis meglumine (PF-06291826) 20 mg or 80 mg in comparison to placebo in subjects diagnosed with transthyretin cardiomyopathy (TTR-CM).

The objective of this study is to determine the efficacy, safety, and tolerability of tafamidis in subjects with transthyretin cardiomyopathy.The primary objective is to assess the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg…

Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial.

The primary objective is to compare metformin versus no intervention for incidence of GDM in women with a high risk for GDM. The main secondary objective is pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.

A Phase 3b, Multi-center, Randomized-withdrawal, Placebocontrolled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant
Polycystic Kidney Disease

To compare the efficacy of tolvaptan treatment in reducing the change in estimated glomerular filtration rate (eGFR) from pre-treatment baseline to post-treatment followup, as compared with placebo, in subjects with late-stage chronic kidney disease…