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NCT ID: NCT01037309 Completed - Clinical trials for Duchenne Muscular Dystrophy

Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD)

Start date: December 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to see whether PRO044 is safe and effective to use as medication for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.

NCT ID: NCT01037231 Completed - Clinical trials for Primary Hyperoxaluria

Phase 2/3 Oxabact Study

Start date: December 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

NCT ID: NCT01036438 Completed - Venous Leg Ulcers Clinical Trials

Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

NCT ID: NCT01035255 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

PARADIGM-HF
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

NCT ID: NCT01035190 Completed - Clinical trials for Bronchopulmonary Dysplasia

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

NEuroSIS
Start date: April 2010
Phase: Phase 3
Study type: Interventional

HYPOTHESIS: Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA. SECONDARY OBJECTIVES: To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen. RATIONALE: Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

NCT ID: NCT01035164 Completed - Alzheimer's Disease Clinical Trials

Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers

Start date: June 2007
Phase: Phase 1
Study type: Interventional

PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.

NCT ID: NCT01034995 Completed - Major Depression Clinical Trials

A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

AGATE
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Primary Objective: - To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. Secondary Objectives: - To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder - To evaluate plasma concentrations of SSR125543

NCT ID: NCT01034618 Completed - Diabetes Clinical Trials

Protein Hydrolyzation and Glycemic Control

Start date: December 2007
Phase: N/A
Study type: Interventional

The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.

NCT ID: NCT01034605 Completed - Obesity Clinical Trials

The Effect of PinnoThin on Satiety and Food Intake

PinnoThin
Start date: December 2008
Phase: N/A
Study type: Interventional

Based upon an increased secretion of gastrointestinal satiety hormones (CCK, GLP-1), PinnoThin is hypothesized to be more satiating, and to limit energy intake in humans. Therefore, the objective of this study is to investigate whether PinnoThin leads to an increase in satiety as determined by VAS ratings? Additionally, does PinnoThin consumed during breakfast, in comparison to placebo, in overweight women, lead to a decrease in energy intake during an ad libitum lunch?

NCT ID: NCT01034293 Completed - Glucose Metabolism Clinical Trials

Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning

Start date: October 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.