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NCT ID: NCT01131676 Completed - Clinical trials for Diabetes Mellitus, Type 2

BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

NCT ID: NCT01129596 Completed - Alzheimer's Disease Clinical Trials

Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Start date: June 10, 2010
Phase:
Study type: Observational

The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.

NCT ID: NCT01128842 Completed - Clinical trials for Advanced Malignant Solid Tumors

A Study Of Neratinib (HKI-272) And Capecitabine In Japanese With Solid Tumor

Start date: April 2010
Phase: Phase 1
Study type: Interventional

This is an open-label, phase 1 study of a single cohort of neratinib (HKI-272) in combination with capecitabine.

NCT ID: NCT01128738 Completed - Hyperhidrosis Clinical Trials

GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

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

The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.

NCT ID: NCT01127477 Completed - Clinical trials for Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.

NCT ID: NCT01126697 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies

Start date: February 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The study will include 120 participants aged 8 and up with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies that have no clinical cardiac symptoms. Participants will be randomized to one of four arms: Arm 1 CoQ10 alone, Arm 2 Lisinopril alone, Arm 3 CoQ10 and Lisinopril or Arm 4 No study medication. Randomization will be stratified by ambulatory status and corticosteroid use. The primary outcome for the study is the myocardial performance index (MPI), measured by standard Doppler echocardiography. The study will last 24 months with visits at Months 0.5,1.5, 6, 12, 18 and 24. Following completion of the Clinical Trial of Coenzyme Q10 and Lisinopril, participants will be offered participation in a companion protocol: PITT1215 A Natural History Companion Study to PITT0908: Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies. The objective of this study is to evaluate the longitudinal natural history of DMD, BMD, and LGMD2I and to evaluate the effects of Coenzyme Q10 and/or Lisinopril on prevention of cardiac dysfunction in these disorders.This will be an 18-month longitudinal natural history study designed to accompany the Clinical Trial of Coenzyme Q10 and Lisinopril in Muscular Dystrophies.

NCT ID: NCT01125670 Completed - Healthy Volunteer Clinical Trials

A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet

Start date: February 2010
Phase: Phase 1
Study type: Interventional

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.

NCT ID: NCT01125657 Completed - Healthy Volunteer Clinical Trials

A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B

Start date: February 2010
Phase: Phase 1
Study type: Interventional

This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.

NCT ID: NCT01125631 Completed - Alzheimer's Disease Clinical Trials

Multiple Intravenous Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Start date: May 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to examine the safety and tolerability of a multiple dose of PF-04360365 administered over approximately 10 minutes in Japanese patients with mild-to-moderate Alzheimer's disease and to characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in Japanese patients with mild-to-moderate Alzheimer's disease.

NCT ID: NCT01125566 Completed - Breast Neoplasms Clinical Trials

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Start date: June 22, 2010
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment