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NCT ID: NCT00328601 Completed - Clinical trials for Diabetic Polyneuropathy

Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2)

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

The primary objective of the trial is to determine the optimal dose of orally (tablet) administered thioctic acid in the treatment of symptoms of diabetic polyneuropathy (dPNP). It is expected that at least one of the three dosages to be tested (600, 1200, or 1800 mg tablets) of orally administered thioctic acid improves the symptoms of dPNP as compared to placebo. Secondary objectives are evaluations of other variables pertinent to dPNP, safety, and tolerability.

NCT ID: NCT00328172 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

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

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

NCT ID: NCT00327015 Completed - Diabetes Clinical Trials

A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

NCT ID: NCT00325780 Completed - Clinical trials for Hypercholesterolemia

Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

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

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

NCT ID: NCT00324155 Completed - Melanoma Clinical Trials

Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

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

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

NCT ID: NCT00322348 Completed - Clinical trials for Advanced Breast Cancer

Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women

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

The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks. Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years

NCT ID: NCT00321919 Completed - Anemia Clinical Trials

A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia

Start date: July 2000
Phase: Phase 3
Study type: Interventional

This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

NCT ID: NCT00321763 Completed - Influenza Clinical Trials

Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

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

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

NCT ID: NCT00320463 Completed - Hepatitis B Clinical Trials

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

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

In this study, infants will be randomly allocated into three groups: - one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) - the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) - the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

NCT ID: NCT00319254 Completed - Breast Neoplasms Clinical Trials

Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

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

The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.