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NCT ID: NCT00805168 Completed - Clinical trials for Pneumonia, Bacterial

Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

INHALE 2
Start date: May 28, 2013
Phase: Phase 3
Study type: Interventional

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

NCT ID: NCT00804856 Completed - Clinical trials for Leukemia, Myeloid, Acute

Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Start date: November 27, 2008
Phase: Phase 2
Study type: Interventional

The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.

NCT ID: NCT00803673 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Healthy Volunteer Study With Inhaled GSK573719 and Placebo

Start date: May 5, 2008
Phase: Phase 1
Study type: Interventional

This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers

NCT ID: NCT00803205 Completed - Cystic Fibrosis Clinical Trials

Study of Ataluren (PTC124™) in Cystic Fibrosis

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 trial that will evaluate the clinical benefit of ataluren in adult and pediatric participants with CF due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve pulmonary function and whether the drug can safely be given for a long period of time. The study will also assess the effects of ataluren on CF pulmonary exacerbation frequency, cough frequency, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology.

NCT ID: NCT00802945 Completed - Breast Cancer Clinical Trials

Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer

Start date: October 2008
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting. Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.

NCT ID: NCT00802373 Completed - Clinical trials for Urinary Bladder, Overactive

Solifenacin Succinate Versus Tolterodine 4mg Once Daily

STAR
Start date: July 2003
Phase: Phase 3
Study type: Interventional

Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

NCT ID: NCT00801957 Completed - Atopic Dermatitis Clinical Trials

Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis

Start date: March 2003
Phase: Phase 2
Study type: Interventional

Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.

NCT ID: NCT00801944 Completed - Clinical trials for Urinary Bladder, Overactive

Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms

SUNRISE
Start date: April 2004
Phase: Phase 3
Study type: Interventional

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

NCT ID: NCT00801242 Completed - Prostate Cancer Clinical Trials

Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

Start date: December 2008
Phase: Phase 3
Study type: Interventional

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

NCT ID: NCT00800618 Completed - Endometriosis Clinical Trials

A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women