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NCT ID: NCT00423891 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

Start date: June 30, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

NCT ID: NCT00423657 Completed - Clinical trials for Bacterial Infections

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

NCT ID: NCT00422526 Completed - Preterm Birth Clinical Trials

Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

Start date: September 2003
Phase: Phase 3
Study type: Interventional

The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

NCT ID: NCT00422383 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

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

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

NCT ID: NCT00419835 Completed - Clinical trials for Macroalbuminuric Diabetic Nephropathy

Effect of Enalapril and Losartan Association Therapy on Proteinuria and Inflammatory Biomarkers in Diabetic Nephropathy: a Clinical Trial on Type 2 Diabetes Mellitus

Start date: May 2005
Phase: Phase 4
Study type: Interventional

Chronic kidney disease (CKD)has become a significant health problem worldwide. Strategies to decrease the rate of progression of this disease and reduce the number of patients needing dialysis or renal transplantation are urgently needed. In this study we wish to compare the effect of dual blockade of renin-angiotensin system (ACE inhibitors plus angiotensin II receptor blocker) compared to the effect of ACE inhibitor monotherapy in patients with diabetic chronic nephropathy.

NCT ID: NCT00419744 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

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

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

NCT ID: NCT00418236 Completed - Breast Cancer Clinical Trials

Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density

Start date: October 2006
Phase: Phase 4
Study type: Observational

It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense. At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects. This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.

NCT ID: NCT00417209 Completed - Clinical trials for Pancreatic Neoplasms

Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen

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

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

NCT ID: NCT00417079 Completed - Neoplasms Clinical Trials

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

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

This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

NCT ID: NCT00415194 Completed - Clinical trials for Head and Neck Neoplasms

A Study for Patients With Head and Neck Cancer

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

This study will compare the effects of pemetrexed plus cisplatin versus cisplatin alone in head and neck cancer patients.