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NCT ID: NCT00680563 Terminated - Anemia Clinical Trials

A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

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

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00680186 Completed - Thromboembolism Clinical Trials

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

RE-COVER II
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

NCT ID: NCT00680056 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients

Start date: November 2007
Phase: Phase 4
Study type: Interventional

The primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via Aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via Handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. The study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

NCT ID: NCT00679588 Completed - Clinical trials for Venous Thromboembolism

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

SAVE-ABDO
Start date: April 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery. The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

NCT ID: NCT00679146 Completed - Low Back Pain Clinical Trials

Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain

TIOKET
Start date: April 2008
Phase: Phase 3
Study type: Interventional

Primary Objective : To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset Secondary Objective : To compare the safety of the oral combination to that of oral TCC alone

NCT ID: NCT00678678 Completed - Obesity Clinical Trials

Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)

Start date: n/a
Phase: N/A
Study type: Interventional

Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery. Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.

NCT ID: NCT00678535 Completed - Gastric Cancer Clinical Trials

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

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

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

NCT ID: NCT00678392 Completed - Kidney Neoplasms Clinical Trials

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Start date: September 3, 2008
Phase: Phase 3
Study type: Interventional

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

NCT ID: NCT00677664 Active, not recruiting - Clinical trials for Diabetic Retinopathy

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

Start date: July 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effects of Copaxone injections in retinal function and integrity in diabetic patients who underwent pan-retinal photocoagulation.

NCT ID: NCT00677053 Completed - Clinical trials for Acute Coronary Syndrome

Safety and Efficacy of TAK-442 in Subjects With Acute Coronary Syndromes

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

The purpose of this study is to determine the safety and tolerability of multiple doses of TAK-442once daily, (QD) or twice daily (BID), in subjects with acute coronary syndrome (unstable angina, myocardial infarction).