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NCT ID: NCT00035451 Completed - Atrial Fibrillation Clinical Trials

Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

NCT ID: NCT00035334 Completed - Clinical trials for Rheumatoid Arthritis

Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis

Start date: October 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.

NCT ID: NCT00034268 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

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

The purposes of this study are to determine: 1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone. 2. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs. 3. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed. LY900003 may not add any benefit to gemcitabine plus cisplatin.

NCT ID: NCT00034190 Completed - Clinical trials for Colorectal Adenocarcinoma

Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Colorectal Adenocarcinoma

Start date: March 2002
Phase: Phase 2
Study type: Interventional

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV colorectal adenocarcinoma.

NCT ID: NCT00034164 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer

Start date: April 2002
Phase: Phase 2
Study type: Interventional

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed stage IIIB or IV non small cell lung cancer.

NCT ID: NCT00022672 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Start date: January 2001
Phase: Phase 3
Study type: Interventional

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

NCT ID: NCT00021775 Completed - HIV Infections Clinical Trials

HIV Prevention Preparedness Study in Russia, China, and India

Start date: April 2002
Phase: N/A
Study type: Observational

The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world. In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.

NCT ID: NCT00021255 Completed - Breast Neoplasms Clinical Trials

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Start date: April 2001
Phase: Phase 3
Study type: Interventional

Primary objective: - Compare disease-free survival in women with HER2-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin. Secondary objective: - Compare overall survival of patients treated with these regimens. - Compare the toxic effects (including cardiac) of these regimens in these patients. - Compare quality of life of patients treated with these regimens. - Compare pathologic and molecular markers for predicting efficacy of these regimens in these patients. - For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in patients treated with these regimens.

NCT ID: NCT00013897 Completed - HIV Infections Clinical Trials

A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine

Start date: February 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).

NCT ID: NCT00005918 Completed - HIV Infections Clinical Trials

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

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

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).