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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: NCT00284518 Completed - Clinical trials for Benign Prostatic Hyperplasia

Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

Start date: December 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

NCT ID: NCT00283959 Completed - Fabry Disease Clinical Trials

A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Start date: June 27, 2006
Phase: Phase 2
Study type: Interventional

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) and how migalastat works in participants with Fabry disease.

NCT ID: NCT00283062 Completed - Prostatic Neoplasms Clinical Trials

Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

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

This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate - Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) - Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to - Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) - Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) - Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: - The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: - To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups - To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. - To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

NCT ID: NCT00282984 Completed - Smoking Cessation Clinical Trials

Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

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

The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.