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NCT ID: NCT01444287 Completed - Myopia Clinical Trials

Daytime Corneal Swelling During Wear of Narafilcon B Lenses

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

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.

NCT ID: NCT01442636 Completed - Clinical trials for Peripheral Arterial Disease

Drug Eluting Stents In The Critically Ischemic Lower Leg 2

DESTINY 2
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.

NCT ID: NCT01442194 Completed - Multiple Sclerosis Clinical Trials

Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

PASSAGE
Start date: August 1, 2011
Phase:
Study type: Observational

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

NCT ID: NCT01440946 Completed - Hemophilia B Clinical Trials

Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B

Kids B-LONG
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01438944 Completed - Smoking Clinical Trials

Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction

Start date: July 2011
Phase: Phase 1
Study type: Interventional

Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine receptor up-regulation through an observational study using nicotine replacement therapy for two weeks and no intervention for two weeks.

NCT ID: NCT01438840 Completed - Clinical trials for Immune Thrombocytopenia

Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)

Start date: February 16, 2012
Phase: Phase 3
Study type: Interventional

Core Study: To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura) (ITP) as measured by cumulative number of weeks of platelet response over 6 months of once daily treatment in adults participants who received at least 1 prior ITP therapy. Extension Phase: To evaluate the safety and tolerability of long-term therapy with avatrombopag in participants with chronic ITP (cITP).

NCT ID: NCT01438229 Completed - Hypertension Clinical Trials

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

EnligHTN-I
Start date: October 2011
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

NCT ID: NCT01437787 Completed - Clinical trials for Hematopoietic Neoplasm

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

JAKARTA
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: - To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. - To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the durability of splenic response. - To evaluate the safety of IMP.

NCT ID: NCT01437566 Completed - Breast Cancer Clinical Trials

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.