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NCT ID: NCT00448591 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

NCT ID: NCT00447902 Terminated - HIV Infections Clinical Trials

Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation

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

The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

NCT ID: NCT00443118 Completed - Resuscitation Clinical Trials

Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?

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

A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.

NCT ID: NCT00441727 Completed - Gastric Ulcer Clinical Trials

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Oberon
Start date: February 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

NCT ID: NCT00440271 Terminated - HIV Infections Clinical Trials

SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

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

The primary purpose of this study is to: 1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) experienced with documented resistance to more than one PI. 2. Determine pharmacokinetic data in this racially and gender diverse population. 3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

NCT ID: NCT00439647 Completed - Male Osteoporosis Clinical Trials

Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Start date: December 2006
Phase: Phase 3
Study type: Interventional

This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.

NCT ID: NCT00439517 Completed - Clinical trials for Previously Untreated Metastatic Colorectal Cancer

Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.

FUTURE
Start date: February 2007
Phase: Phase 2
Study type: Interventional

This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

NCT ID: NCT00437645 Completed - Clinical trials for Essential Hypertension

Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension

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

This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

NCT ID: NCT00437294 Terminated - Breast Cancer Clinical Trials

Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

NCT ID: NCT00434369 Active, not recruiting - Breast Cancer Clinical Trials

5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients

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

A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10 methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and taxane chemotherapy regimens.