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NCT ID: NCT00545688 Completed - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Start date: June 2006
Phase: Phase 2
Study type: Interventional

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00545090 Completed - Clinical trials for Post Menopausal Osteoporosis

ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

Start date: August 2006
Phase: Phase 4
Study type: Interventional

This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00543725 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

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

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

NCT ID: NCT00540449 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

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

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

NCT ID: NCT00539734 Completed - Clinical trials for Age-related Macular Degeneration

Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

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

Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

NCT ID: NCT00537329 Completed - Candidemia Clinical Trials

Anidulafungin In Treatment Of Candidemia In Asian Subjects

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

The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

NCT ID: NCT00531479 Completed - Aspergillosis Clinical Trials

Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

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

This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

NCT ID: NCT00529451 Completed - Hypertension Clinical Trials

Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

Start date: September 2007
Phase: Phase 3
Study type: Interventional

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

NCT ID: NCT00528567 Completed - Breast Cancer Clinical Trials

BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

Start date: December 2007
Phase: Phase 3
Study type: Interventional

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. The secondary objectives of this trial are to: - compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab - evaluate the safety and tolerability of bevacizumab An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

NCT ID: NCT00528151 Completed - Clinical trials for Optic Atrophy, Hereditary, Leber

A Randomized, Double-blind, Placebo-controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

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

Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production. Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation. Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.