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NCT ID: NCT00745589 Completed - Clinical trials for Endstage Renal Disease

Sevelamer Hydrochloride in Peritoneal Dialysis Patients

SERENE
Start date: July 2008
Phase: N/A
Study type: Interventional

To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

NCT ID: NCT00745225 Completed - Clinical trials for End-stage Renal Disease

Peroxisome Proliferator-Activated Receptor-Gamma Activation in Peritoneal Dialysis Patients

PPAR
Start date: February 2006
Phase: Phase 4
Study type: Interventional

To study whether peroxisome proliferator-activated receptor-gamma activation in peritoneal dialysis patients will reduce inflammation, atherosclerosis, calcification and improve survival of peritoneal dialysis patients

NCT ID: NCT00741260 Completed - Breast Cancer Clinical Trials

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Start date: December 9, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group. Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level. In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone. The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors. The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1. The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine. Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.

NCT ID: NCT00735397 Completed - Epilepsy Clinical Trials

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

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

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

NCT ID: NCT00735137 Completed - Preterm Birth Clinical Trials

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

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

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of <25 mm in length and in twin pregnancies.

NCT ID: NCT00721123 Completed - Clinical trials for Rheumatoid Arthritis

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis

Start date: August 2005
Phase: Phase 3
Study type: Interventional

This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

NCT ID: NCT00720798 Completed - Clinical trials for Rheumatoid Arthritis

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Start date: September 2005
Phase: Phase 3
Study type: Interventional

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

NCT ID: NCT00719264 Completed - Clinical trials for Carcinoma, Renal Cell

Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

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

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

NCT ID: NCT00718861 Completed - Clinical trials for Post-menopausal Osteoporosis

3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

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

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

NCT ID: NCT00716079 Completed - Stroke Clinical Trials

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

INTERACT2
Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.