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NCT ID: NCT00607685 Completed - Glaucoma Clinical Trials

5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy

Start date: February 2008
Phase: Phase 4
Study type: Interventional

Trabeculectomy is the most effective method of lowering intraocular pressure in glaucoma that is not well controlled with drop medication. The post-operative wound healing response remains the major barrier in surgical success. Scar tissue formation results in occlusion of the surgical drainage site created. As a consequence, the intraocular pressure rises once again. The current use of anti-scarring agents such as 5 Fluorouracil (5FU), is a well established method employed by ophthalmologists to clinically reduce the postoperative scarring response. However, in patients with a high risk of bleb failure, repeated subconjunctival injections of 5FU following bleb needling is often required resulting in increased clinical load and patient inconvenience. A slow release formulation of 5FU would be of benefit by releasing the 5FU into the subconjunctival space over an extended period thereby providing a prolonged therapeutic effect. In addition, hyaluronic acid is known to possess antifibrotic properties and from its gel-like physical state, would potentially act as a physical tissue spacer that may further limit active subconjunctival scarring at the site where it is injected. We hypothesise that injecting a mixture of 5FU with hyaluronic acid would give better outcomes than injecting 5FU alone. The aim of this study is to determine whether bleb needling with subconjunctival injection of Viscoelastic/5FU formulation is an effective method for prolonged drug delivery in preventing the post-operative scarring response. This will be a prospective case-controlled study involving patients who have already undergone trabeculectomy and who require bleb needling and subconjunctival 5FU injections.

NCT ID: NCT00607373 Completed - Clinical trials for Hypercholesterolemia

Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia

RADICHOL 1
Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.

NCT ID: NCT00605111 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

Start date: December 2003
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.

NCT ID: NCT00604422 Completed - Ulcerative Colitis Clinical Trials

Evaluation of the PillCamâ„¢ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis

Start date: April 2007
Phase:
Study type: Observational

To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis

NCT ID: NCT00600626 Completed - Clinical trials for Diabetes Mellitus, Type 2

Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Start date: January 2004
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

NCT ID: NCT00576823 Completed - Neurogenic Bladder Clinical Trials

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Alfahydro
Start date: December 2007
Phase: Phase 3
Study type: Interventional

Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology. Secondary objectives were: - To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents, - To investigate the number of Urinary Tract Infection (UTI) episodes, - To investigate the pharmacokinetics of Alfuzosin (population kinetics).

NCT ID: NCT00574873 Completed - Clinical trials for Chronic Myeloid Leukemia

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Start date: February 5, 2008
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

NCT ID: NCT00571649 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

MAGELLAN
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

NCT ID: NCT00567489 Completed - Diabetes Clinical Trials

IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

Impendia
Start date: January 2008
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.