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NCT ID: NCT00290953 Completed - Lung Cancer Clinical Trials

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

SESAME
Start date: October 2002
Phase: Phase 2/Phase 3
Study type: Interventional

To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide. Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm. Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.

NCT ID: NCT00289640 Completed - Melanoma Clinical Trials

Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

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

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

NCT ID: NCT00288600 Completed - Hyperbilirubinemia Clinical Trials

Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease

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

The use of intravenous immunoglobulin G (IVIG) therapy has been reported in hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human Immunoglobulin is considered an alternative to delay the hemolytic process and consequently reduce the number of exchange transfusions and transfusions of red cells concentrate, thus diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To determine the effect of IVIG in decreasing the incidence and severity of neonatal immune hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical trial involving all newborns with risk of significant hyperbilirubinemia due to direct Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion and others are: incidence of late anemia, kernicterus and deafness Babies were randomly assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg); and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in the first 6 hours of life. Exchange transfusion was carried out in any group if at any time the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent will be asked in pre-natal time.

NCT ID: NCT00287196 Completed - Malignant Melanoma Clinical Trials

Immediate Radiotherapy or Observation After Surgery for Melanoma Involving Lymph Nodes

Start date: March 2002
Phase: Phase 3
Study type: Interventional

This trial seeks to establish the role of post-operative radiotherapy in patients who have had surgery for melanoma involving lymph nodes and who are at high risk of recurrence.

NCT ID: NCT00286494 Completed - Diabetes Mellitus Clinical Trials

Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

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

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus

NCT ID: NCT00286468 Completed - Diabetes Mellitus Clinical Trials

Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

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

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.

NCT ID: NCT00286455 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

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

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), in adults with type 2 diabetes.

NCT ID: NCT00286442 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

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

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

NCT ID: NCT00286429 Completed - Diabetes Mellitus Clinical Trials

Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

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

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

NCT ID: NCT00284128 Completed - Hypertension Clinical Trials

AVE7688 in Patients With Mild to Moderate Blood Pressure

RAVEL-1
Start date: December 2005
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12. The secondary objectives are: - To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough systolic blood pressure at the end of week 12 - To compare the percentages of responders after 12 week of treatment - To evaluate the long term safety and tolerability of AVE 7688 with particular attention to angioedema