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NCT ID: NCT00174785 Completed - Atrial Fibrillation Clinical Trials

A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation

ATHENA
Start date: June 2005
Phase: Phase 3
Study type: Interventional

To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population.

NCT ID: NCT00174759 Completed - Clinical trials for Arterial Occlusive Diseases

CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease

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

Primary objective: To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD. Secondary objectives: Comparison, between the two treatment groups, of : - Primary patency, - Assisted primary patency, - Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle. - Ankle Brachial Pressure Index (ABPI) changes from baseline

NCT ID: NCT00174668 Completed - Clinical trials for Diabetes Mellitus, Type 2

Insulin Glulisine in Diabetes Mellitus, Type 2

GINGER
Start date: November 2004
Phase: Phase 3
Study type: Interventional

Primary objective: The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint. Secondary objectives: Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

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: NCT00171990 Completed - Clinical trials for Recurrent Genital Herpes

Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

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

This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes. This study is not recruiting patients in the United States.

NCT ID: NCT00171912 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Start date: September 2004
Phase: Phase 2
Study type: Interventional

This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

NCT ID: NCT00171821 Completed - Clinical trials for Transfusion-dependent Iron Overload

A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-dependent Iron Overload

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

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

NCT ID: NCT00171730 Completed - Acromegaly Clinical Trials

An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

Start date: August 24, 2004
Phase: Phase 2
Study type: Interventional

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

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: 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.