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NCT ID: NCT00808132 Completed - Osteoporosis Clinical Trials

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Start date: January 2009
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

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: 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: 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.

NCT ID: NCT00799903 Completed - Atherosclerosis Clinical Trials

The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial

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

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

NCT ID: NCT00795808 Completed - Clinical trials for Polycystic Ovary Syndrome

PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

PCOSMIC
Start date: August 2003
Phase: Phase 4
Study type: Interventional

1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI </= 32). 3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.

NCT ID: NCT00792753 Completed - Clinical trials for Coronary Artery Disease

Elixir Medical Clinical Evaluation of the Novolimus-Eluting Coronary Stent System: A Randomized Study "EXCELLA II STUDY"

Start date: October 2008
Phase: N/A
Study type: Interventional

Randomized Study To evaluate the safety and effectiveness of the Elixir Medical DESyne Novolimus-Eluting Coronary Stent System with Durable Polymer through the assessment of clinical, angiographic and IVUS endpoints as compared to the concurrently enrolled Medtronic Zotarolimus-Eluting Coronary Stent System in a randomized, single blind study of up to 200 male and female patients. In a Continued Access Registry of up to 100 patients receiving the DESyne Stent clinical-only endpoints will be evaluated. To evaluate the safety and effectiveness of the Elixir Novolimus-Eluting Coronary Stent System with bioabsorbable polymer as compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System control through clinical and angiographic endpoints.

NCT ID: NCT00790036 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

PILLAR2
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy

NCT ID: NCT00787657 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis (RRMS)

Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment

BEACON
Start date: June 2008
Phase: N/A
Study type: Observational

- The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression. - The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.