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NCT ID: NCT00606580 Completed - Clinical trials for Cutaneous Leishmaniasis

Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

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

This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.

NCT ID: NCT00602745 Terminated - Neoplasm Metastasis Clinical Trials

S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen

S-1 Pancreas
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

NCT ID: NCT00565448 Completed - Carcinoma Clinical Trials

Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

Start date: November 2007
Phase: Phase 2
Study type: Interventional

The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC). The secondary objectives are to determine: - the safety of TCF in comparison to CF after induction treatment of NPC, - the pharmacokinetics of docetaxel when added to CF, - the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.

NCT ID: NCT00564187 Completed - Hypertension Clinical Trials

Evaluation of Efficacy and Safety of the Dosage Adjustment of Aprovel® (Irbesartan) in Hypertensive Outpatients in Current Clinical Practice

Start date: February 2003
Phase: Phase 4
Study type: Interventional

Primary: - To evaluate the efficacy of two regimens of irbesartan in patients responding but not normalized at 6 weeks of treatment (schema N°1: maintenance 150 mg/day, schema n°2: 300 mg/day for 6 more weeks) Secondary: - To evaluate the percentage of patients with DBP < 90 mmHg at 6 and 12 weeks - To evaluate the percentage of patients with SBP < 140 mmHg at 6 and 12 weeks - To evaluate rate of adverse events during the study

NCT ID: NCT00558103 Completed - Neoplasms, Breast Clinical Trials

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

NCT ID: NCT00553631 Completed - Clinical trials for Gaucher Disease, Type 1

Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease

Start date: January 29, 2008
Phase: Phase 3
Study type: Interventional

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this non-inferiority study is to evaluate the efficacy and safety of GA-GCB (velaglucerase alfa) administered every other week in comparison to imiglucerase in treatment naive patients with type 1 Gaucher disease.

NCT ID: NCT00500604 Completed - Hypertension Clinical Trials

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

COSIMA2
Start date: July 2007
Phase: Phase 4
Study type: Interventional

The primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (SBP) as measured by home blood pressure monitoring (HBPM) after 24 weeks compared with baseline. The secondary objectives are: - To compare the percentage of patients with normal blood pressure as measured by HBPM and at the doctor's office at weeks 16 and 24 - To compare the differences in mean Diastolic Blood Pressure (DBP), mean morning and evening SBP and DBP evaluated by HBPM at weeks 16 and 24 - To compare the difference in mean SBP evaluated by HBPM at week 16 - To compare the differences in mean SBP and DBP evaluated at the doctor's office at weeks 16 and 24 - To determine the incidence and severity of adverse events

NCT ID: NCT00490230 Completed - Scar Clinical Trials

Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

SCAR
Start date: April 2007
Phase: N/A
Study type: Interventional

Primary Objectives: Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)

NCT ID: NCT00489736 Completed - Atrial Fibrillation Clinical Trials

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

DIONYSOS
Start date: June 2007
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

NCT ID: NCT00485979 Completed - Breast Neoplasms Clinical Trials

Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

SATIN
Start date: June 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria). The secondary objectives are: - to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria, - to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.