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NCT ID: NCT00079482 Completed - Clinical trials for Acute Myeloid Leukemia

Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

Start date: October 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

NCT ID: NCT00078338 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Start date: February 16, 2004
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

NCT ID: NCT00078312 Completed - Clinical trials for Sleep Apnea, Obstructive

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).

NCT ID: NCT00077857 Completed - Breast Cancer Clinical Trials

A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Start date: July 2003
Phase: Phase 2
Study type: Interventional

This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.

NCT ID: NCT00077792 Completed - Clinical trials for Myocardial Infarction

Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment Thrombolysis in Myocardial Infarction - Study 25 (ExTRACT-TIMI25)

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

The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

NCT ID: NCT00077753 Completed - Clinical trials for Venous Thromboembolism

EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

Start date: February 2002
Phase: Phase 4
Study type: Interventional

Primary objective: - To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: - To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis - To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study - To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: - Major and minor hemorrhage - Heparin induced thrombocytopenia - Serious adverse events - To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

NCT ID: NCT00077597 Completed - Anemia Clinical Trials

A Study of Mircera for the Treatment of Anemia in Dialysis Patients

Start date: February 2004
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

NCT ID: NCT00076336 Completed - Cirrhosis Clinical Trials

Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

Start date: December 2003
Phase: Phase 3
Study type: Interventional

This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

NCT ID: NCT00076076 Completed - Asthma Clinical Trials

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

NCT ID: NCT00075270 Completed - Neoplasms, Breast Clinical Trials

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.