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NCT ID: NCT00895895 Terminated - Alzheimer Disease Clinical Trials

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

Start date: May 2009
Phase: Phase 2
Study type: Interventional

The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).

NCT ID: NCT00893620 Terminated - Iliac Aneurysms Clinical Trials

Zenith(R) Connection Endovascular Covered Stent Clinical Study

Start date: January 2010
Phase: N/A
Study type: Interventional

The Zenith(R) Connection Endovascular Covered Stent Clinical Study is a clinical investigation to study the safety and performance of the Zenith(R) Connection Endovascular Covered Stent in conjunction with the Zenith(R) Branch Endovascular Graft-Iliac Bifurcation in the treatment of aorto-iliac and iliac aneurysms.

NCT ID: NCT00880009 Terminated - Breast Cancer Clinical Trials

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Start date: July 30, 2009
Phase: Phase 2
Study type: Interventional

This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

NCT ID: NCT00862082 Terminated - Clinical trials for Hepatocellular Carcinoma

Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The current understanding of PR104 justifies the evaluation of PR104 with sorafenib in patients with hepatocellular carcinoma. These include: - Hypoxia. Hepatocellular Carcinoma (HCC) is likely to demonstrate a level of hypoxia sufficient to activate PR104 to its active metabolites PR104H and PR104M. In addition, in preclinical models, sorafenib has been demonstrated to increase the degree of hypoxia in tumors following treatment. - Non-overlapping toxicity. PR104 and sorafenib do not share major toxicities. It is anticipated that both drugs can be administered at their full single agent dose when used in combination. - Aldo-keto reductase 1C3 (AKR1C3). HCC has been shown to express high levels of AKR1C3 which should lead to selective activation of PR104 within both hypoxic and oxic HCC cells. - Preclinical data. The use of sorafenib and PR104 alone and in combination in a hepatocellular carcinoma model demonstrates activity of PR104 as a single agent and increased activity when PR104 and sorafenib are used in combination. The current study will provide an estimate of the activity of PR104 in subjects with HCC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in HCC to warrant a larger phase III registration study in this indication. Primary objectives - Phase I: Determine the maximum tolerated dose (MTD) of PR104 when used in combination with standard dose sorafenib - Phase II: Estimate the response rate (RR) of PR104/sorafenib [Note: Phase II was never initiated] Secondary objectives - Evaluate survival - Evaluate Progression Free Survival (PFS) - Evaluate time to progression (TTP) - Evaluate safety - Evaluate the pharmacokinetics (PK) of sorafenib, PR104 and PR104 metabolites - Collect diagnostic biopsy samples for the determination of aldo-keto reductase 1C3 - Collect plasma samples for assessment of potential biomarkers of tumor hypoxia

NCT ID: NCT00858364 Terminated - Cancer Clinical Trials

Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

Start date: July 17, 2009
Phase: Phase 3
Study type: Interventional

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

NCT ID: NCT00849667 Terminated - Ovarian Cancer Clinical Trials

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

Start date: April 16, 2009
Phase: Phase 3
Study type: Interventional

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

NCT ID: NCT00816010 Terminated - Clinical trials for Type 2 Diabetes Mellitus

Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes

Start date: July 2008
Phase: N/A
Study type: Interventional

Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to usual clinic-based care.

NCT ID: NCT00793546 Terminated - Clinical trials for Advanced Breast Cancer

Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

Start date: February 2009
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

NCT ID: NCT00737360 Terminated - Clinical trials for Head and Neck Cancer

Phase II Study of TAS-106 to Treat Head and Neck Cancer

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.

NCT ID: NCT00704847 Terminated - Osteoarthritis Clinical Trials

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee