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NCT ID: NCT00174655 Completed - Breast Neoplasms Clinical Trials

BIG 02/98 Docetaxel - Breast Cancer

Start date: June 1998
Phase: Phase 3
Study type: Interventional

Primary objectives: - To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: - To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes - To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes - To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy). - To compare overall survival of treatment arms. - To compare toxicity of treatment arms. - To evaluate pathologic and molecular markers for predicting efficacy. - Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.

NCT ID: NCT00172133 Completed - Osteoporosis Clinical Trials

Open Label Extension Study of PREOS

OLES
Start date: October 16, 2001
Phase: Phase 3
Study type: Interventional

This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.

NCT ID: NCT00172081 Completed - Osteoporosis Clinical Trials

TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

Start date: April 27, 2000
Phase: Phase 3
Study type: Interventional

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH [1-84]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

NCT ID: NCT00171340 Completed - Breast Cancer Clinical Trials

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

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

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

NCT ID: NCT00171210 Completed - Clinical trials for Transfusional Iron Overload in ß-thalassemia

An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

Start date: October 2004
Phase: Phase 3
Study type: Interventional

A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

NCT ID: NCT00170209 Completed - Clinical trials for Latent Tuberculosis Infection

Rifampin Versus Isoniazid for the Treatment of Latent Tuberculosis Infection in Children (P4v9)

Start date: August 2011
Phase: Phase 3
Study type: Interventional

Tuberculosis (TB) is spread by airborne transmission from adults with active contiguous TB to children, especially those living in the same household. Once children are exposed and infected they are at very high risk to develop active TB - which can be lethal if not detected and treated promptly. This makes it very important to detect TB infection as soon as possible, and treat this while it is still latent or dormant. Current therapy for latent TB infection is 9 months of Isoniazid; this is very effective if taken properly but because treatment is so long many children do not finish this. Four months of Rifampin is a recommended alternative. In adults this has been shown to be safer with much higher completion rates. However the effectiveness of this treatment is unclear, and is being studied in an ongoing study. The investigators plan to compare the safety as well as the acceptability and effectiveness of 4 months Rifampin with 9 months Isoniazid (standard treatment) in children in several sites in Canada and other countries. It is hypothesized that among children at high risk for development of active TB, intolerance/adverse events will not be worse (non-inferiority), among those randomized to 4RIF compared to those randomized to 9INH. In addition completion of latent tuberculosis infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of active TB will not be significantly higher (non-inferiority) in children taking 4RIF.

NCT ID: NCT00168857 Completed - Hypertension Clinical Trials

A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy (AMADEO Study)

Start date: July 9, 2003
Phase: Phase 4
Study type: Interventional

A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).

NCT ID: NCT00168337 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

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

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

NCT ID: NCT00168298 Completed - Macular Edema Clinical Trials

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Start date: November 1, 2004
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

NCT ID: NCT00166244 Completed - Clinical trials for De Novo Renal Transplant Recipient.

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.