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NCT ID: NCT00808067 Completed - Atrial Fibrillation Clinical Trials

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

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

The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

NCT ID: NCT00808028 Completed - Clinical trials for Meningitis, Meningococcal

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

NCT ID: NCT00806923 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00806819 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

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

The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.

NCT ID: NCT00804141 Completed - Constipation Clinical Trials

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

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

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

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: NCT00801255 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients

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

This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

NCT ID: NCT00800683 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

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

to determine safety, efficacy and tolerability of BI 1356 versus placebo

NCT ID: NCT00800579 Completed - Cystic Fibrosis Clinical Trials

Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers

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

The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.

NCT ID: NCT00800436 Completed - Breast Cancer Clinical Trials

A Dose Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and HER2 Positive Female Patients

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

This 2 part study will select the subcutaneous(sc) dose of Herceptin which results in comparable exposure to intravenous(iv) Herceptin in healthy male volunteers and in HER2 positive female patients, and will assess the safety and tolerability of the 2 formulations. In the first part of the study, 4 cohorts of subjects will be treated with a single dose of Herceptin as follows: Cohort 1--6mg/kg iv in healthy male volunteers; Cohort 2--6mg/kg iv in female patients; Cohort 3--6mg/kg sc in healthy male volunteers; Cohort 4 --10mg/kg sc in healthy male volunteers. In part 2 of the study, the chosen sc dose (<12mg/kg)will be confirmed in female patients. Patients will receive a maximum of 2 doses of Herceptin, and the target sample size is <100 individuals.