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NCT ID: NCT01574326 Completed - Clinical trials for Chronic Kidney Disease

An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

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

Objective: In hyperphosphatemic pediatric patients with chronic kidney disease (CKD) to - Evaluate the safety and tolerability of sevelamer carbonate - Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

NCT ID: NCT01572038 Completed - Breast Neoplasms Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

PERUSE
Start date: June 1, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

NCT ID: NCT01568164 Completed - Heart Failure Clinical Trials

Safety and Efficacy Study of the BioVentrix PliCath HF System

CONFIGURE-HF
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

NCT ID: NCT01568138 Completed - Heart Failure Clinical Trials

Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

CONFIGURE-HF
Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy. Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating, unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass pump (CBP).

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01565967 Completed - Trauma Clinical Trials

Registry AutoLog Lipid Removal and Blood Component Characterization

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

NCT ID: NCT01557244 Completed - Clinical trials for Urinary Bladder, Neurogenic

A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

Start date: July 2, 2012
Phase: Phase 3
Study type: Interventional

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

NCT ID: NCT01555151 Completed - Asthma Clinical Trials

Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

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

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.

NCT ID: NCT01544595 Completed - Clinical trials for Moderate to Severe Plaque-type Psoriasis

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Start date: June 19, 2012
Phase: Phase 3
Study type: Interventional

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

NCT ID: NCT01541228 Completed - Actinic Keratosis Clinical Trials

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Start date: April 2010
Phase: N/A
Study type: Interventional

Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.