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NCT ID: NCT01908829 Completed - Urologic Diseases Clinical Trials

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

BESIDE
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

NCT ID: NCT01905943 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

Start date: November 4, 2013
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

NCT ID: NCT01902628 Completed - Anemia Clinical Trials

OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

OPTIMA
Start date: July 15, 2013
Phase:
Study type: Observational

This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

NCT ID: NCT01901146 Completed - Breast Cancer Clinical Trials

Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Women With HER2-positive Early Breast Cancer

Lilac
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the effectiveness and safety of ABP 980 against trastuzumab in women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

NCT ID: NCT01897545 Completed - Atrial Fibrillation Clinical Trials

Combined Treatment of Arterial Hypertension and Atrial Fibrillation

Start date: April 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant/non-resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.

NCT ID: NCT01896895 Completed - Clinical trials for Bilateral Blepharospasm (BEB)

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This phase 3 study will serve to collect efficacy and safety data of two different doses of NT 201 in subjects suffering from Bilateral Blepharospasm (BEB) who are BTX treatment-naïve. In this study, BTX treatment-naïve subjects are defined as those who have not received BTX treatment within the last 12 months for the treatment of BEB. This definition aims to avoid bias by comparison of treatment effects in the subject's assessments. Furthermore, this study will substantiate the existing efficacy and safety database for the indication BEB.

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01894438 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease

Start date: April 2013
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver fat >5-10% of liver weight), not due to excess alcohol consumption or other causes of steatosis. At present, no medication or surgical procedure has been approved for treating NAFLD and lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for overweight subjects and at prevention of overweight for the normal weight individuals. Given that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the resolution of the metabolic syndrome, the main aim of the present study is to implement and evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a sample of patients with NAFLD.